Minimally invasive access device and method

ABSTRACT

A device that provides access to a surgical location within a patient has an elongate body that has a proximal end, a distal end, and an inner surface. The inner surface defines a passage that extends through the elongate body. The elongate body is capable of having a configuration when inserted within the patient wherein the cross-sectional area of the passage at a first location is greater than the cross-sectional area of said passage at a second location. The first location is distal to the second location. The passage is capable of having a generally oval shaped cross section between the second location and the proximal end.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This application relates to components of surgical systems, including adevice for providing minimally invasive access at a surgical site, andto methods that may be performed therethrough.

2. Description of the Related Art

Spinal surgery presents significant difficulties to the physicianattempting to reduce chronic back pain or correct spinal deformitieswithout introducing additional trauma due to the surgical procedureitself. In order to access the vertebrae to perform spinal procedures,the physician is typically required to make large incisions and cut orstrip muscle tissue surrounding the spine. In addition, care must betaken not to injure nerve tissue in the area. Consequently, traditionalsurgical procedures of this type carry high risks of scarring, pain,significant blood loss, and extended recovery times.

Apparatuses for performing minimally invasive techniques have beenproposed to reduce the trauma of posterior spinal surgery by reducingthe size of the incision and the degree of muscle stripping in order toaccess the vertebrae. One such apparatus provides a constant diametercannula which is made narrow in order to provide a small entry profile.As a result, the cannula provides minimal space for the physician toobserve the body structures and manipulate surgical instruments in orderto perform the required procedures. A narrow cannula is typicallyinconvenient if not insufficient to perform many spinal procedures, someof which require visualization of two or more vertebrae and introductionof various components and tools for applying such components.

Also, such a cannula is ineffective in procedures where the surgicalsite is an elongate site, extending between two adjacent vertebrae.While a certain length is needed to span the distance between thevertebrae, a corresponding width is not required in order to insertcomponents for treatment and tools. Accordingly, either more adjacenttissue must be exposed than needed or a second cannula must be inserted.In either case, the benefits of a minimally invasive procedure arelessened.

SUMMARY OF THE INVENTION

In one embodiment a device for retracting tissue provides access to aspinal location within a patient. The device has an elongate body thathas a proximal end and a distal end. The elongate body has a lengthbetween the proximal and distal ends such that the distal end can bepositioned inside the patient adjacent the spinal location. The elongatebody has a generally oval shaped proximal portion and an expandabledistal portion. A passage extends through the elongate body between theproximal and distal ends. The passage is defined by a smooth metal innersurface extending substantially entirely around the perimeter of thepassage between the proximal and distal ends. The elongate body isexpandable between a first configuration sized for insertion into thepatient and a second configuration wherein the cross-sectional area ofthe passage at the distal end is greater than the cross-sectional areaof the passage at the proximal end.

In another embodiment, a device provides access to a surgical locationwithin a patient. The device has an elongate body that has a proximalend, a distal end, and an inner surface. The inner surface defines apassage that extends through the elongate body. Surgical instruments canbe inserted through the passage to the surgical location. The elongatebody is capable of having a configuration when located within thepatient wherein the cross-sectional area of the passage at a firstlocation is greater than the cross-sectional area of the passage at asecond location. The first location is distal to the second location.The passage is capable of having an oblong shaped cross section betweenthe second location and the proximal end.

In another embodiment, a device provides access to a surgical locationwithin a patient. The device has an elongate body that has a proximalend, a distal end, and an inner surface. The inner surface defines apassage that extends through the elongate body. Surgical instruments canbe inserted through the passage to the surgical location. The elongatebody is expandable from a first configuration to a second configurationwhen located within the patient. In the second configuration thecross-sectional area of the passage at a first location is greater thanthe cross-sectional area of the passage at a second location. The firstlocation is distal to the second location. The passage is capable ofhaving a generally oval shaped cross section between the second locationand the proximal end.

In another embodiment, a device provides access to a surgical locationwithin a patient. The device has an elongate body that has a proximalend, a distal end, and an inner surface. The inner surface defines apassage that extends through the elongate body. Surgical instruments canbe inserted through the passage to the surgical location. The elongatebody is capable of having a configuration when inserted within thepatient wherein the cross-sectional area of the passage at a firstlocation is greater than the cross-sectional area of the passage at asecond location. The first location is distal to the second location.The passage is capable of having a cross section between the secondlocation and the proximal end. The cross section is defined by first andsecond generally parallel opposing side portions and first and secondgenerally arcuate opposing side portions.

In another embodiment, a method for accessing a surgical location withina patient comprises providing a device that has an elongate body. Theelongate body has a proximal end, a distal end, and an inner surface.The inner surface defines a passage extending through the elongate body.Surgical instruments can be inserted through the passage to the surgicallocation. The passage is capable of having an oblong shaped crosssection between the second location and the proximal end. The elongatebody has an expanded configuration. The elongate body is configured forinsertion into the patient. The device is inserted into the patient tothe surgical location. The device is expanded to the expandedconfiguration.

In another embodiment, a device provides access to a surgical locationwithin a patient. The device has an elongate body that has a proximalend, a distal end, and an inner surface. The inner surface defines apassage that extends through the elongate body. Surgical instruments canbe inserted through the passage to the surgical location. The elongatebody is capable of having a configuration when located within thepatient wherein the cross-sectional area of the passage at a firstlocation is greater than the cross-sectional area of the passage at asecond location. The first location is distal to the second location. Alighting element is coupled with the elongate body to provide light tothe surgical location.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features of the present invention will becomemore apparent to one skilled in the art upon consideration of thefollowing description of the invention and the accompanying drawings inwhich:

FIG. 1 is an exploded perspective view of a surgical cannula accordingto one embodiment of the present invention, the cannula being shown inan expanded condition;

FIG. 2 is a perspective view of the cannula of FIG. 1 with parts removedfor clarity, the cannula being shown in a contracted condition;

FIG. 3 is a schematic end view showing the cannula of FIG. 1 in theexpanded condition;

FIG. 4 is a rollout view of a part of the cannula of FIG. 1;

FIG. 5 is a schematic sectional view of the cannula of FIG. 1 during asurgical procedure.

FIG. 6 is a schematic view of a support apparatus constructed accordingto another embodiment;

FIG. 7 is a schematic view taken along line 7-7 in FIG. 6;

FIG. 8 is a schematic view taken along line 8-8 in FIG. 6 showing partof the support of FIG. 6;

FIG. 9 is a schematic view taken along line 9-9 in FIG. 6 showing partof the support apparatus of FIG. 6;

FIG. 10 is a schematic view taken along line 10-10 in FIG. 6 with partsremoved;

FIG. 11 is a schematic view taken along line 11-11 in FIG. 6;

FIG. 12 is a schematic view taken along line 12-12 in FIG. 6 showingpart of the support apparatus of FIG. 6;

FIG. 13 is a schematic view taken along line 13-13 in FIG. 6 showingpart of the support apparatus of FIG. 6;

FIG. 14 is a perspective view of the support apparatus of FIG. 6;

FIG. 15 is a perspective view of the support apparatus of FIG. 6 lookingat the support apparatus from an angle different than FIG. 13;

FIG. 16 is a perspective view of the support apparatus of FIG. 6 lookingat the support apparatus from an angle different than FIGS. 14 and 15;

FIG. 17 is a sectional view taken approximately along line 17-17 of FIG.9;

FIG. 18 is an enlarged view of a part of FIG. 17;

FIG. 19 is a schematic view taken along line 19-19 in FIG. 10 with partsremoved;

FIG. 20 is a view further illustrating parts shown in FIG. 10;

FIG. 21 is a view taken approximately along line 21-21 of FIG. 20;

FIG. 22 is a schematic view showing the support apparatus with anassociated known mechanical arm;

FIG. 23 is a schematic view of another feature of part of the supportapparatus of FIG. 6;

FIG. 24 is a schematic view of a fixation assembly attached to vertebraeof a patient;

FIG. 25 is a schematic view taken along line 25-25 of FIG. 24;

FIG. 26 is an exploded schematic view of part of the assembly of FIG.24;

FIG. 27 is a schematic view of another fixation assembly attached tovertebrae of a patient;

FIG. 28 is a schematic view taken along line 28-28 of FIG. 27;

FIG. 29 is an exploded schematic view of part of the assembly of FIG.27;

FIG. 30 is an exploded view of part of a cutting tool according toanother embodiment;

FIG. 31 is an assembled view of part of the cutting tool of FIG. 30;

FIG. 32 is a perspective view of a surgical system and procedureaccording to another embodiment;

FIG. 33 is a perspective view of a cannula or expandable conduit in areduced profile configuration according to another embodiment;

FIG. 34 is a perspective view of the expandable conduit of FIG. 33 in afirst enlarged configuration;

FIG. 35 is a perspective view of the expandable conduit of FIG. 33 in asecond enlarged configuration;

FIG. 36 is a view of a cannula skirt according to another embodiment;

FIG. 37 is a view of a cannula skirt according to another embodiment;

FIG. 38 is a perspective view of a cannula or expandable conduit in anenlarged configuration according to another embodiment.

FIG. 39 is an enlarged sectional view of the expandable conduit of FIG.38 taken along lines 39-39 of FIG. 38;

FIG. 40 is a sectional view of the expandable conduit of FIG. 38 takenalong lines 40-40 of FIG. 38;

FIG. 41 is a perspective view of a cannula or expandable conduit in anenlarged configuration according to another embodiment;

FIG. 42 is an enlarged sectional view of the expandable conduit of FIG.41 taken along lines 42-42 of FIG. 41;

FIG. 43 is a sectional view of the expandable conduit of FIG. 41 takenalong lines 43-43 of FIG. 41;

FIG. 44 is a view of a portion of a cannula or expandable conduitaccording to another embodiment;

FIG. 45 is a view of a portion of a cannula or expandable conduitaccording to another embodiment;

FIG. 46 is a sectional view illustrating an early stage of a procedureaccording to another embodiment;

FIG. 47 is a side view of another apparatus in a reduced profileconfiguration according to another embodiment;

FIG. 48 is a side view of the apparatus of FIG. 47 in an expandedconfiguration;

FIG. 49 is a sectional view of the apparatus of FIGS. 47-48 insertedinto the expandable conduit of FIG. 33;

FIG. 50 is a sectional view of the apparatus of FIGS. 47-48 insertedinto the expandable conduit of FIG. 33;

FIG. 51 is a perspective view with parts separated of further apparatusaccording to another embodiment;

FIG. 52 is a top view of the apparatus of FIG. 51 illustrated with otherapparatus;

FIG. 53 is a side view of the apparatus of FIG. 51 illustrated withother apparatus;

FIG. 54 is an enlarged perspective view of a component of the apparatusof FIG. 51;

FIG. 55 is a perspective view of further apparatus according to anotherembodiment;

FIG. 56 is a view in partial section of a later stage in the procedureaccording to another embodiment;

FIG. 57 is a perspective view of a spinal implant or fusion deviceconstructed according to another embodiment showing a first side surfaceof the spinal implant;

FIG. 58 is a perspective view of the spinal implant of FIG. 57 showing asecond side surface of the spinal implant;

FIG. 59 is a plan view of the spinal implant of FIG. 57 showing an uppersurface of the spinal implant;

FIG. 60 is a side view of the spinal implant of FIG. 57 showing thefirst side surface;

FIG. 61 is a cross-sectional view of the spinal implant taken along theline 61-61 in FIG. 60;

FIG. 62 is a perspective view of another embodiment of a spinal implantconstructed according to another embodiment showing a first side surfaceof the spinal implant;

FIG. 63 is a perspective view of the spinal implant of FIG. 62 showing asecond side surface of the spinal implant;

FIG. 64 is a plan view of the spinal implant of FIG. 62 showing an uppersurface of the spinal implant;

FIG. 65 is a side view of the spinal implant of FIG. 62 showing thefirst side surface;

FIG. 66 is a cross-sectional view of the spinal implant taken along theline 66-66 in FIG. 65;

FIG. 67 is a view showing a pair of the spinal implants of FIG. 57 infirst relative positions between adjacent vertebrae;

FIG. 68 is a view showing a pair of the spinal implants of FIG. 57 insecond relative positions between adjacent vertebrae;

FIG. 69 is a view showing the spinal implant of FIG. 62 between adjacentvertebrae;

FIG. 70 is a view showing a spinal implant being inserted between theadjacent vertebrae according to another embodiment;

FIG. 71 is a side view of an apparatus according to another embodiment;

FIG. 72 is a front view of the apparatus of FIG. 71;

FIG. 73 is a top view of the apparatus of FIG. 71;

FIG. 74 is a back view of the apparatus of FIG. 71;

FIG. 75 is a bottom view of the apparatus of FIG. 71;

FIG. 76 is a sectional view of the apparatus of FIG. 71, used inconjunction with additional structure in a patient;

FIG. 77 is a longitudinal sectional view of the apparatus of FIG. 76taken from line 77-77 of FIG. 76;

FIG. 78 is a transverse sectional view of the apparatus of FIG. 77 takenfrom line 78-78 of FIG. 77;

FIG. 79 is a sectional view, similar to FIG. 76, illustrating analternative position of the apparatus of FIG. 71;

FIG. 80 is a sectional view, similar to FIG. 76, illustrating anotheralternative position of the apparatus of FIG. 71;

FIG. 80 a is a transverse sectional view of the apparatus of FIG. 80,taken along lines 80 a-80 a of FIG. 80;

FIG. 81 is a side view, similar to FIG. 71, of another apparatus;

FIG. 82 is a front view, similar to FIG. 74, of the embodiment of FIG.81;

FIG. 83 is a sectional view, similar to FIG. 76, of the apparatus ofFIGS. 81-82, used in conjunction with additional structure in a patient;

FIG. 84 is a transverse sectional view of the apparatus of FIGS. 81-82,taken along lines 84-84 of FIG. 83;

FIG. 85 is a perspective view of an apparatus according to anotherembodiment;

FIG. 86 is a perspective view with parts separated of the apparatus ofFIG. 85;

FIG. 86 a is an enlarged side view of a component illustrated in FIG.86;

FIG. 87 is a perspective view of a surgical instrument according toanother embodiment;

FIG. 88 is an enlarged sectional view of the apparatus of FIGS. 85-87,illustrating a further stage of the procedure;

FIG. 89 is side view of a surgical instrument according to anotherembodiment;

FIG. 90 is a view in partial section of a stage in the procedureaccording to another embodiment;

FIG. 91 is a side view of an instrument according to another embodiment;

FIG. 92 is a perspective view similar to FIG. 90 illustrating theapparatus of FIGS. 85 and 91, in a further stage of the procedureaccording to another embodiment;

FIG. 93 is an enlarged sectional view of the apparatus of FIGS. 85 and91, illustrating a still further stage according to another embodiment;

FIG. 94 is an enlarged sectional view similar to FIG. 93, illustrating asubsequent stage of the procedure according to another embodiment;

FIG. 95 is an enlarged view in partial section illustrating anotherstage in the procedure in according to another embodiment;

FIG. 96 is a reduced scale view in partial section illustrating yetanother stage in the procedure according to another embodiment;

FIG. 97 is a perspective view of an access device according to anotherembodiment;

FIG. 98 is a side perspective view of the access device of FIG. 97;

FIG. 99 is a perspective view of the access device of FIG. 97 in apivoted configuration;

FIG. 100 is an end view of the access device of FIG. 97;

FIG. 101 is an exploded perspective view of the access device of FIG. 97in an expanded configuration with some portions shown in hidden line;

FIG. 102 is a perspective view of the access device of FIG. 97 in acontracted configuration with some portions shown in hidden line;

FIG. 103 is a partial sectional view of the access device of FIG. 97 inan early stage of a procedure;

FIG. 104 is a perspective view of a portion of one embodiment of asurgical system that includes an access device, a support arm, and alighting element shown applied to a patient;

FIG. 105 is a perspective side view of the surgical system of FIG. 104shown applied to a patient;

FIG. 106 is a top view of the surgical system of FIG. 104;

FIG. 107 is a perspective view of one embodiment of a lighting element;

FIG. 108 is a perspective view of another embodiment of a lightingelement; and

FIG. 109 is a perspective view of another embodiment of a lightingelement.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The application is directed to surgical systems that may include adevice for providing minimally invasive access at a surgical site and avariety of tools that can be used to perform various procedures at thesurgical site. Also disclosed herein are a number of components, e.g.,implants, that may be applied to the spine at various spinal locationsin connection with such procedures. Various embodiments of accessdevices and related components that are particularly advantageous inprocedures that are convenient to perform at an elongate surgical siteare discussed below in connection FIGS. 97-109. However, a variety ofadvantageous combinations may be provided whereby features of theseembodiments are combined with features of other embodiments describedhereinbelow.

One embodiment of a surgical system described hereinbelow isparticularly well suited for performing various methods for fixing thevertebrae of a patient at a surgical site. As discussed more fullybelow, such a surgical system generally includes an access device, suchas an expandable cannula or conduit, an adjustable support for theaccess device, a variety of surgical instruments, a viewing device, alighting element, a spinal implant or fusion device, and a vertebralfixation assembly. Many of these components, e.g., the instruments,viewing device, spinal implants, and fixation assembly components, areconfigured to be inserted through the access device to the surgicalsite.

FIGS. 1-5 illustrate one suitable expandable cannula or conduit 10constructed for use in a method according to one embodiment. The cannula10 is a tubular structure 12 centered on an axis 14. The tubularstructure 12 defines a passage 16 through the cannula 10. Surgicalinstruments are inserted into the body during surgery through thepassage 16.

The tubular structure 12 comprises a first tubular portion 20 and asecond tubular portion 40 attached to the first tubular portion. Thefirst tubular portion 20 is preferably made of a length of stainlesssteel tubing, but could alternatively be made of another suitablematerial. The first tubular portion 20 has a proximal end 22 and adistal end 24. Parallel cylindrical inner and outer surfaces 26 and 28,respectively, extend between the ends 22, 24 of the first tubularportion 20. The inner surface 26 defines a first passage portion 30 ofthe passage 16 through the cannula 10. The first passage portion 30 hasa diameter D1 that is preferably in the range from 10 mm to 30 mm.

The second tubular portion 40 of the tubular structure 12 is attached tothe distal end 24 of the first tubular portion 20. The second tubularportion 40 is preferably made from stainless steel, but couldalternatively be made from another suitable material.

As best seen in the rollout view of FIG. 4, the second tubular portion40 comprises an arcuate segment 42 of sheet stock. The arcuate segment42 includes first and second arcuate edges 44 and 46, respectively, andfirst and second planar edges 48 and 50, respectively. The first andsecond planar edges 48 and 50 are rolled in an overlapping manner toform the tubular configuration of the second tubular portion 40.

When the second tubular portion 40 has been rolled into its tubularconfiguration, the first and second arcuate edges 44 and 46 defineoppositely disposed first and second ends 60 and 62 (FIGS. 1 and 2),respectively, of the second tubular portion. The first and second ends60 and 62 are connected by a central portion 64. The first end 60 of thesecond tubular portion 40 is attached to the distal end 24 of the firsttubular portion 20 by a single fastener, such as a rivet 66. The rivet66 extends through two aligned apertures 68 (FIG. 4) at the first end 60of the second tubular portion 40. The first end 60 of the second tubularportion 40 is pivotable about the rivet 66.

The second tubular portion 40 includes parallel inner and outer surfaces70 and 72 (FIGS. 1 and 2), respectively, extending between the first andsecond ends 60 and 62. The inner surface 70 defines a second passageportion 74 of the passage 16 through the cannula 10 that extends as acontinuation of the first passage portion 30 in the first tubularportion 20.

An arcuate slot 80 is formed in the second tubular portion 40 andextends between the inner and outer surfaces 70 and 72 of the secondtubular portion. The arcuate slot 80 extends along a curvilinear path inthe central portion 64 of the second tubular portion 40 toward thesecond end 60 of the second tubular portion. The arcuate slot 80 has afirst terminal end 82 located in the central portion 64 of the secondtubular portion 40. A second terminal end 84 of the arcuate slot 80 islocated adjacent the intersection of the second arcuate edge 46 and thefirst planar edge 48 of the arcuate segment 42.

A guide pin 90 is attached to the inner surface 70 of the second tubularportion 40 adjacent the intersection of the second arcuate edge 46 andthe second planar edge 50. In the tubular configuration of the secondtubular portion 40, the guide pin 90 is located in the arcuate slot 80and is movable along the curvilinear path of the arcuate slot. A washer92 is secured to an inner end of the guide pin 90 to retain the guidepin in the arcuate slot 80.

The second tubular portion 40 of the tubular structure 12 is expandablefrom a contracted condition shown in FIG. 2 to an expanded conditionshown in FIG. 1. In the contracted condition, the guide pin 90 islocated in the first terminal end 82 of the arcuate slot 80 in thesecond tubular portion 40 and the second passage portion 74 defined bythe second tubular portion is cylindrical in shape. The second passage74 has a generally constant diameter D2 (FIGS. 2 and 3) that isapproximately equal to the diameter D1 of the first tubular portion 20.Thus, the cross-sectional area of the second passage portion 74 at thesecond end 62 of the second tubular portion 40, which is function of thediameter D2, is approximately the same as the cross-sectional area atthe first end 60 of the second tubular portion and is approximately thesame as the cross-sectional area of the first passage portion 30 in thefirst tubular portion 20.

In the expanded condition, the guide pin 90 is located in the secondterminal end 84 of the arcuate slot 80 in the second tubular portion 40and the second tubular portion has a conical configuration. At thesecond end 62 of the second tubular portion 40, the second passageportion 74 has a diameter D3 (FIG. 3) that is larger than the diameterD2 of the second passage portion at the first end 60. Preferably, thediameter D3 of the second passage portion 74 at the second end 62 of thesecond tubular portion is 40% to 80% greater than the diameter D1 of thesecond passage portion at the first end 60. Thus, in the expandedcondition, the cross-sectional area of the second passage portion 74 atthe second end 62 of the second tubular portion 40, which is function ofthe diameter D3, is 16% to 64% greater than the cross-sectional area ofthe second passage portion at the first end 60 of the second tubularportion. In the expanded condition, the cross-sectional area of thesecond passage portion 74 at the second end 62 of the second tubularportion 40 is large enough to overlie a major portion of at least twoadjacent vertebrae.

The cannula 10 includes an outer layer 100 (FIG. 1) for maintaining thesecond tubular portion 40 of the cannula in the contracted condition. Itis contemplated that other suitable means for maintaining the secondtubular portion 40 in the contracted condition could be employed. Inaccordance with a preferred embodiment of the present invention, theouter layer 100 comprises a section of plastic tubing 102 which is heatshrunk over both the first and second tubular portions 20 and 40 to holdthe second tubular portion in the contracted condition.

In addition, a loop of polyester string 104 for tearing the heat shrunktubing 102 is wrapped around the heat shrunk tubing so that it extendsboth underneath and on top of the tubing. An outer end 106 of the string104 extends beyond the tubing 102.

FIG. 1 shows an actuatable device 111 for expanding the second tubularportion 40 from the contracted condition to the expanded condition. Inaccordance with a preferred embodiment, the actuatable device 111comprises a manually operated expansion tool 112. The expansion tool 112resembles a common pair of scissors and has a pair of legs 114 pivotallyconnected to one another. The expansion tool 112 includes afrustoconical end section 116 formed by a pair of frustoconical halves118. Each of the frustoconical halves 118 extends from a respective oneof the legs 114 of the expansion tool 112. It is contemplated that othersuitable means for expanding the second tubular portion 40 toward theexpanded condition could be employed, such as an inflatable balloon (notshown).

During an endoscopic surgical procedure, the cannula 10 is inserted intothe body of a patient in the contracted condition. The outer end 106 ofthe string 104 is then manually pulled on by the surgeon. Pulling on thestring 104 tears the heat shrunk tubing 102 most of the way along theheat shrunk tubing, which frees the second tubular portion 40 forexpansion. The heat shrunk tubing 102, in its torn condition, remainsattached or secured to the first tubular portion 20.

Next, the expansion tool 112 is inserted into the passage 16 in thecannula 10 until the frustoconical end section 114 is located at thesecond end 62 of the second tubular portion 40. The legs 114 of theexpansion tool 112 are manually separated, causing the frustoconicalhalves 118 to separate also. As the halves 118 separate, a radiallyoutward directed force is exerted on the inner surface 70 of the secondtubular portion 40 by the halves 118, causing the second tubular portionto expand toward the expanded condition. Under the force of theexpanding expansion tool 112, the guide pin 90 slides from the firstterminal end 82 of the arcuate slot 80 to the second terminal end 84 ofthe arcuate slot to permit the expansion of the second tubular portion40. The expansion tool 112 can be rotated about the axis 14 to ensurethat the second tubular portion 40 of the cannula 10 is completelyexpanded to the expanded condition. The expansion tool 112 is thencollapsed and removed so that one or more surgical instruments(indicated schematically at 21 in FIG. 5) and a viewing element can bereceived through the cannula 10 and inserted into a patient's body 130.The expandable second tubular portion 40 of the cannula 10 provides asignificantly larger working area for the surgeon inside the body 130within the confines of the cannula.

The expanded tubular portion 40 can dilate and locally retract andseparate spinalis muscle and soft tissues from the vertebrae therebycreating an endoscopic operating field at the surgical site. Thisendoscopic operating field within the spinal muscles differs fromarthroscopic, laparoscopic, or cystoscopic working spaces in that thereis no physiologic space or defined tissue plane that can be insufflatedwith air or distended with fluid.

FIGS. 6-23 illustrate one suitable support apparatus for use in a methodaccording to one embodiment. The support apparatus 110 includes a firstsupport 120, a second support 140, a first adjustment mechanism 160, asecond adjustment mechanism 180, and a third adjustment mechanism 900.

As viewed in FIGS. 9 and 15, the first support 120 is associated withthe cannula 10 and has a circular perimeter 121. The perimeter 121 has acenter 122 located on the axis 14. The first support 120 comprises acircular platform, or disk 124, which has a circular opening 126 in thecentral area of the disk 124 for receiving the proximal end 22 of thecannula 10. The circular opening 126 has a center located on the axis14. The proximal end 22 of the cannula 10 can be easily inserted intoand removed from the opening 126. The disk 124 has a projection portion120 a, which is located adjacent the perimeter 121 of the disk 124. Thedisk 124 has an upper circular surface area 124 a, which surrounds theopening 126.

As viewed in FIG. 15, the second support 140 supports a viewing device200 including a camera head 201 and an endoscope 202 with a rod and lensassembly 203, herein referred to as a viewing element, extending downthrough the passage 16 of the cannula 10. With reference to FIGS. 15 and16, the second support 140 includes a body 142 having an opening 144through which the viewing device 200 extends and a clamp 146 forclamping the viewing device 200 to the body 142 in the opening 144. Theclamp 146 includes a threaded set screw 148 for securing the viewingdevice 200 to the body 142. The set screw 148 has a manually rotatableknob 148 a and a stem threaded into the body 142. When rotated, thescrew 148 moves axially relative to the body 142 to clamp or release theviewing device 200 depending on the direction of rotation of the screw148.

The body 142 of the second support 140 further includes two extensionarms 151, 152 (FIG. 8) for supporting the endoscope 202. Each extensionarm 151, 152 includes a threaded bore for receiving a resilient detentmember, or ball plunger 400.

As viewed in FIGS. 17 and 18, a ball plunger 400 is illustrated atanother location in the support apparatus 110. Each ball plunger 400,including those in the extension arms 151, 152, has an externallythreaded tubular body 402 with a cylindrical cavity 404 located therein.The cavity 404 houses a projection 406 and a coiled spring 408. Theprojections 406 of the two ball plungers 400 of the extension arms 151,152 are spherical detent members 420 in the form of balls (not shown).The spring 408 urges each projection 406 against a lip portion 409 ofthe body 402. The lip portion 409 is located at one end of the cavity404. As shown in FIG. 18, the other ball plungers 400 of the apparatus10 have projections 406 with hemispherical extensions 420 and shoulderportions 422.

As viewed in FIG. 15, the endoscope 202 has corresponding hemisphericalrecesses (not shown) for receiving the spherical detent members (balls)of the ball plungers 400 which are located in extension arms 151, 152.The springs 408 will compress in each ball plunger 400 in each extensionarm 151, 152 and the spherical detent members will move inward of eachcavity 404 and then spring back into the hemispherical recesses in theendoscope 202, as the endoscope 202 is inserted between the extensionarms 151, 152. The entire viewing device 200 will thus be securedbetween the extension arms 151, 152, but may be removed by overcomingthe force of the spherical detent members of each ball plunger 400 inthe extension arms 151, 152.

The ball plunger 400 further includes a head portion 430 with a slot 432for engaging a tool, such as a screwdriver. The ball plunger 400 may bethreadedly adjusted within the threaded bore of either extension arm151, 152 to alter the distance that the spherical detent member 420projects away from the extension arms 151, 152 (toward each other). Thisdistance, along with the stiffness of each spring 408, will determinethe holding force by which the endoscope 202 is secured between theextension arms 151, 152.

The first adjustment mechanism 160 provides for relative axialadjustment of the cannula 10 and the first support 120 along the axis14. The first adjustment mechanism 160 includes a first toothed rackmember 162, a cannula gripper mechanism 164 fixedly connected to thefirst rack member 162, a first manually adjustable, rotatable knob 166rotatably carried by the projection portion 120 a of the first support120, and a first gear member 165 (FIG. 12) rotatable by the first knob166 and in meshing engagement with the teeth 163 of the first rackmember 162. The first support 120 and, in particular, the projectionportion 120 a, rotatably carries the first gear member 165 (FIG. 12).

The first rack member 162 is secured to slide axially within the firstsupport 120 and the projection portion 120 a by two ball plungers 400(FIG. 12). One ball plunger 400 is tangentially threaded into a tapered,threaded bore (FIG. 7) in the perimeter 121 of the first support 120 andthe other is tangentially threaded into a threaded bore in theprojection portion 120 a. The hemispherical extensions 420 thusfrictionally engage a smooth portion (without teeth 163) of the firstrack member 162 and bias the first rack member 162 against the firstsupport 120 and the projection portion 120 a. This biasing alsomaintains the engagement of the first rack member 162 and the first gearmember 165 (FIG. 12).

As viewed in FIGS. 10 and 19, the cannula gripper mechanism 164 includestwo gripper arms 172, 174 for clamping against the outer surface of thecannula 10, and a gripper actuating lever 176 for moving the arms 172,174 into engagement with the outer surface of the cannula 10 and forreleasing the arms 172, 174 from engagement with the cannula 10.

As viewed in FIG. 19, the cannula gripper mechanism 164 further includesa support pin 177, a coiled spring 188, a washer 189 with a bore (notshown), and a lock pin 190. The support pin 177 has a head 179, a shaft180, and an elongate, or flat, end 181 that can mate with the bore inthe washer 189. Other suitable structures could be used.

During assembly, the coiled spring 188 is interposed between the arms172, 174. The flat end 181 of the support pin 177 is inserted through acircular bore in the first clamp arm 172, through the coil of the spring188, through a circular bore in the second arm 174, and through the borein the washer 189. The flat end 181 of the support pin 177 is theninserted into a slot 176 a in the lever 176. The lock pin 190 isinserted through a bore in the lever 176 and through a bore in the flatend 181 of the support pin 177 thereby securing the mechanism 164together and allowing the lever 176 to rotate about the lock pin 190. Acamming surface 178 on the lever 176 adjacent the washer 189 forces thearms 172, 174 together to grip the cannula 10 as the lever 176 isrotated clockwise (as viewed in FIG. 10). Counterclockwise rotation ofthe lever 176 allows the spring 188 to force the arms 172, 174 apart andreleases the cannula 10 from the gripper mechanism 164.

When the gripper mechanism 164 is either gripping the cannula 10 orreleased from the cannula 10 and the knob 166 is rotated, the disk 124and parts attached to the disk 124 will move along the axis 14 of thecannula 10 relative to the cannula 10. After the support apparatus 110is initially lined up with the cannula 10, the viewing device 200 may bepositioned on the support apparatus 110 and adjusted along the axis 14by rotation of knob 166.

The second adjustment mechanism 180 provides axial adjustment of thefirst and second supports 120, 140 relative to each other along the axis14. The second adjustment mechanism 180 includes a second toothed rackmember 182 connected to the first support 120, a second manuallyadjustable, rotatable knob 186 rotatably carried by the body 142 of thesecond support 140, and a second toothed gear member 185 (FIG. 13)rotatable by the second knob 186 and in meshing engagement with theteeth 183 of the second rack member 182. The second support 140, and inparticular, the body 142, rotatably carries the second gear member 185(FIG. 13).

The body 142 of the second support 140 may have a notch 149 which canfit around part 902 a of the third adjustment mechanism 900 and allowthe lower surface of the body 142 to completely abut the disk 124 as thebody 142 is brought into an axial position adjacent the disk 124.

The second rack member 182 is secured to slide axially within the secondsupport 140 by a ball plunger 400 (FIG. 13). The ball plunger 400 istangentially threaded into a threaded bore in the side of the notch 149of the second support 140. The hemispherical extension 420 thusfrictionally engages a smooth portion (without teeth 183) of the secondrack member 182 and biases the second rack member 182 against the secondsupport 140. The biasing also maintains the engagement of the secondrack member 182 and the second gear member 185. Both sides of the notch149 have tapered portions 149 a, 149 b for facilitating insertion of theball plunger 400 into the threaded bore of the notch 149 of the secondsupport 140. Rotation of the knob 186 causes the body 142 and theviewing device 200 attached thereto to move relative to the cannula 10and disk 124 along the axis 14.

The third adjustment mechanism 900 provides arcuate, circumferentialadjustment of the second support 140 about the axis 14 relative to thefirst support 120. The third adjustment mechanism 900 includes awedge-shaped support member 902 (FIG. 9) fixedly connecting the secondrack member 182 to a ring member 904 that is rotatably supported by thefirst support 120 and rotatable about the axis 14 relative to the firstsupport 120 (FIG. 17).

The third adjustment mechanism 900 further includes a third manuallyadjustable, rotatable knob 906 that is part of a set screw. The setscrew is rotatably threaded into a projection portion 902 a of thesupport member 902 and is engageable with the circular perimeter 121 ofthe disk 124 of the first support 120 to lock the support member 902 inan arcuate position relative to the first support 120 and the axis 14.

As viewed in FIGS. 17 and 18, the ring member 904 is supported within acylindrical, open ended recess 905 of the first support 120. The recess905 is concentric about the axis 14. The perimeter 904 a of the ringmember 904 has a groove 904 b for engaging a plurality of ball plungers400 (preferably four equally spaced apart) in the first support 120.Each of these ball plungers 400 is similar in construction. Each ballplunger 400 is threaded radially into the perimeter 121 of the firstsupport 120 to provide a hemispherical extension 420 extending into therecess 905 of the first support 120.

The ring member 904 thus is biasingly supported within the recess 905 ofthe first support 120 and can rotatably slide within the recess 905about the axis 14. The ball plungers 400 operatively support the ringmember 904 in the recess 905 of the first support 120. The ring member904, along with the second support 140 and the second and thirdadjustment mechanisms 180, 900, can be easily removed from the recess905 for cleaning, maintenance, etc. of the parts by overcoming the forceapplied by the ball plungers 400 to the ring member 904. When the knob906 is rotated to disengage the perimeter 121 of disk 124, the body 142and parts connected thereto can be manually rotated about the axis 14.This causes the viewing device 200 to rotate about the axis 14 of thecannula 10 and enables the surgeon to view different parts of thesurgical sight as desired.

As viewed in FIG. 16, the fixed connections of the first rack member 162to a support arm 300, the second rack member 182 to the wedge-shapedsupport member 902, and the support member 902 to the ring member 904may be made by one or more suitable metal fasteners 290, such as rivetsor bolts. The entire support apparatus 110 can be constructed from metalor any other suitable material having sufficient mechanical strength anddurability. Certain parts may be made from materials permitting X-raysand other techniques for viewing the surgical sight (i.e., radiolucentparts). Other parts may also be made from non-magnetic materials toreduce electromagnetic interference (i.e., electromagnetic insulatingparts).

With reference to FIGS. 10 and 22, the gripper's arms 172, 174 are apart of the support arm 300 for attaching the support apparatus 110 to amechanical robotic arm 301. The support arm 300 includes an arm portion302 that is formed integrally with the arms 172, 174. The arms 172, 174are integrally constructed with the arm portion 302.

The support arm 300 also includes an arm portion 303. The arm portion303 has an attaching structure 304, including a groove 305, which snapsinto a socket in the mechanical arm 301. Detents of any suitable typeand designated 306 in the mechanical arm 301, hold the arm portion 303in position in the socket in the mechanical arm 301. The detents 306 maybe controlled by external actuation levers (not shown) on the mechanicalarm 301 for manually releasing the arm portion 303 from the mechanicalarm 301.

The arm portions 302 and 303 are pivotally connected to each other by afastener 310. The fastener 310 extends through an opening 311 in the armportion 302 and threads into a threaded opening 312 in the arm portion303. When the fastener 310 is released, the arm portions 302, 303 maypivot relative to each other about a pivot axis 314. The pivot axis 314is centered on the axis of the fastener 310 and the axis of the threadedopening 312. When the fastener 310 is tightly screwed into the threadedopening 312, the arm portions 302, 303 are secured together againstpivoting movement. When the fastener is released, the arm portions 303,302 may pivot relative to each other about the axis 314.

The end of the arm portion 302, which is adjacent to the arm portion303, has a convex surface 350, which is curved about the axis 314. Thearm portion 303 has a concave surface 351, which is also curved aboutthe axis 314. The surfaces 350, 351 move concentrically relative to eachother when the arm portions 303 and 302 pivot relatively about the axis314.

The arm portion 303 has a set of teeth 320 which encircle the axis 314and which project axially toward a set of teeth 321 on the arm portion302. The teeth 321 project axially toward the teeth 320. The teeth 320and the teeth 321 mesh with each other and provide a locking action sothat the arm portions 302, 303 are positively locked against relativemovement about axis 314 when the fastener 310 is tightly screwed intothe opening 312. The teeth 320, 321 comprise a lock which blocksrelative rotation of the arm portions 302, 303 about the axis 314. Whenthe fastener 310 is loosened, the arm portions 302, 303 may be rotatedrelative to each other about the axis 314, and thus, the arm portions302, 303 may pivot relative to each other to adjust the position of thesupport apparatus 110.

A cylindrical projection 325 is welded to the arm portion 303. Thus, theprojection 325 and arm portion 303 are fixedly connected together. Theprojection 325 is centered on the axis 314 and contains a chamber 328.

As viewed in FIG. 20, the chamber 328 communicates with a fluid passage329 in a male fluid connector 331. The male connector 331 attaches to amale connector 333 on the mechanical arm 301 by means of a flexible hose392 so that the fluid passage 329 communicates with a fluid passage inthe mechanical arm 301.

As viewed in FIG. 20, the chamber 328 is closed at its upper end by acap 335. The cap 335 has an opening 336 centered on the axis 314. Theopening 336 communicates with the chamber 328. A manually movableinternal valve member 340 normally closes the opening and blocks thechamber 328 from communicating with the ambient air surrounding thesupport arm 300. The valve member 340 is connected to a stem 341, whichis also centered on the axis 314. The stem 341 has a knob or button 343on its end that may be manually depressed to move the stem 341 and valvemember 340 downward into the chamber 328. When the stem 341 and valvemember 340 are so moved, the chamber 328 is in communication with theambient air surrounding the device due to the unblocking of the opening336.

The mechanical arm 301 is a known device and is of the type generallydisclosed in U.S. Pat. No. 4,863,133, which is incorporated by referencein its entirety herein. The mechanical arm 301 is sold by LeonardMedical, Inc. 1464 Holcomb Road, Huntington Valley, Pa., 19006. Themechanical arm 301 includes relatively movable parts, which permitmovement and adjustment of the support apparatus 110 in a variety inplanes, directions, and orientations. The mechanical arm 301 permitseasy movement when a vacuum is not applied to the arm 301. When a vacuumis applied to the arm 301, relative movement of the parts of the arm 301is resisted, and therefore adjustment of the support apparatus 110 isdifficult.

When the button 343 is depressed, the chamber 328 loses its vacuum andthe pressure in the chamber 328 increases toward ambient pressure. Thepassage 329 communicates this pressure increase to the mechanical arm301, and thus the parts of the mechanical arm 301 are free to move andallow for adjustment of the position of the support apparatus 110 by thesurgeon.

Accordingly, when the surgeon uses the support apparatus 110, thesupport arm 300 is snapped into the socket of the mechanical arm 301where it is held by the detent 306. The surgeon may then depress thebutton 343 and relatively move parts of the mechanical arm 301, as wellas the support apparatus 110 into the position where the surgeon desiresthe support apparatus 110 to be. This position may be where the opening126 in the disk 124 is aligned with the proximal end 16 of the cannula10 that has been positioned in the patient's body with the distal end 24of the cannula 10 being located in an incision in the body of thepatient. The viewing device 200 may be mounted on the support apparatus110, and the surgeon may make adjustments prior to and during thesurgical procedure as desired, as described above.

As viewed in FIG. 23, the support apparatus 110 may include a secondsupport with a fourth adjustment mechanism 500 for rotating the viewingdevice 200 about an axis 501 (FIG. 15) defined by the ball plungers 400of the extension arms 151, 152 when set screw 148 is not clamping theviewing device 200 to the body 142. The axis 501 is offset from the axis14 of the cannula 10 and perpendicular to the axis 14 of the cannula 10.Rotation of the viewing device 200 about axis 501 causes the endoscope200 and the rod and lens assembly 203 to move perpendicular to the axis14 of the cannula 10. This rotation will result in radial adjustment ofthe position of the rod and lens assembly 203 in a radial directiontransverse to the axis 14.

The spring-loaded connections of the spherical detent members 420 of theball plungers 400 and the hemispherical recesses of the endoscope 202allow rotation about the axis 501 when the set screw 148 is releasedfrom clamping engagement of the viewing device 200.

The mechanism 500 includes a threaded bore 510 in the second support 140and an adjustable member 520 for moving (vertically as viewed in theFigs.) a part of the viewing device 200 about the axis 501. Theadjustable member 520 has a rounded first end portion 522, a threadedmiddle portion 524, and a knurled second end portion 526, or knob. Thebore 510 extends at an angle as shown in FIG. 23 from a lower portion ofthe second support 140 up to the opening 144 in the clamp 146 of thesecond support 140.

The adjustable member 520 is rotated and threaded into the bore 510 andmay be rotated until the first end portion 522 protrudes into theopening 144 of the second support 140. Accordingly, when the surgeonwishes to adjust the rod and lens assembly 203 (within the surgicalsight) about the axis 501 and radially relative to the axis 14 of thecannula 10, the surgeon may loosen the connection of the set screw 148with the viewing device 200 and rotate the adjustable member 520 bymanually rotating knob 526 so that the first end portion 522 verticallyextends farther or less into the opening 144. This adjustment willadjust the part of the viewing device 200 engaged by the clamp 146 alongthe axis 14, rotate the viewing device 200 about the axis 501, and causethe lens 203 at the surgical site to move transverse to the axis 14 ofthe cannula 10. This will expand the area of the surgical site that thesurgeon may view. When the adjustment is complete, the surgeon maytighten the set screw 148 and re-secure the viewing device 200 to thesecond support 140 of the support apparatus 110.

The method of securing two vertebrae 601, 602 together according to oneembodiment may include the insertion of a vertebral fixation assembly620 through the cannula 10 and attachment of the vertebral fixationassembly 620 to two vertebrae (such as the L4 and L5 vertebrae), asviewed in FIGS. 24-29. The fixation assembly 620 may be of any suitableconstruction and is shown in FIG. 26 as including four identicalattachment devices 622. Each attachment device 622 includes a threadedfastener 624 or pedicle screw, placed in a vertebra 601 or 602, asviewed in FIGS. 25 & 28. The fastener 624, has a first threaded portion626 with a first threaded diameter that threads into the vertebrae 601,602 by screwing the fastener 624 into the vertebrae. The fastener 624further includes a second threaded portion 628 with a second threadeddiameter that may be less than the first threaded diameter. The secondthreaded portion 628 extends away from the vertebrae 601, 602.

A first hexagonal engagement surface 630, intermediate the first andsecond threaded portions 626, 628, allows gripping of the fastener 624when the fastener is screwed into the vertebrae 601, 602. A first convexengagement surface 632, adjacent the first hexagonal engagement surface630 and the second threaded portion 628, projects away from thevertebrae 601, 602. A second hexagonal engagement surface 634 projectsaway from the second threaded portion 628 and allows further gripping ofthe fastener 624.

Each attachment device 622 further includes a first fixation washer 640(FIGS. 26 & 29) that engages the first convex engagement surface 632.The first fixation washer 640 includes a first concave engagementsurface 642 for abutting and slidingly engaging the first convexengagement surface 632 of the fastener 624.

The first fixation washer 640 further includes spikes 644, typicallythree, extending away from the vertebrae 601, 602. The spikes 644 of thefirst fixation washer 640 engage a lower knurled surface 652 of avertebral fixation element 650 that in FIGS. 24-26 is a spine plate.

An upper knurled surface 654 of the fixation element 650 engages thespikes 664 of a second fixation washer 660 that is identical to thefirst fixation washer 640, but inverted, as viewed in FIGS. 26 & 29. Asecond convex engagement surface 672 of a threaded locking nut 670 abutsand slidingly engages the second concave engagement surface 662 of thesecond fixation washer 660 when the locking nut 670 is loosely threadedonto the second threaded portion 628 of the fastener 624.

The convex and concave engagement surfaces 632, 642, 662, 672 allowangular adjustment of the fixation elements 650, before the locking nut670 is fully tightened, when the fasteners 624 are not threaded into thevertebrae 601, 602 exactly parallel to each other, as shown exaggeratedin FIG. 25. These surfaces may typically allow for up to a 12-degreeoffset of the axes of the two fasteners 624.

One of two types of fixation elements 650 may typically be used tosecure the vertebrae 601, 602 together. The first type may be a spinalplate 651 (FIG. 26) with two slots 653, 655 extending along thelongitudinal axis 657 of the spinal plate. The second threaded portion628 of one fastener 624, screwed into one vertebra 601, extends throughone slot 653 and the second threaded portion 628 of another fastener624, screwed into another vertebra 602, extends through the other largerslot 655. Two of the spinal plates 651, one on each side of thevertebrae 601, 602, are used to secure the two vertebrae together, asviewed in FIG. 24. The slots 653, 655 allow further transverseadjustment so that the same spinal plate 651 may be used for differentsize patients.

A second type of fixation element 650 may be two universal side blocks651 a (FIG. 29), each with one slot 653 a extending along thelongitudinal axis 657 a of each side block and a securement opening 655a extending substantially perpendicularly to each slot 653 a, as viewedin FIG. 29. The second threaded portion 628 of a fastener 624, screwedinto one vertebra 601, extends through one slot 653 a and the secondthreaded portion 628 of another fastener 624, screwed into anothervertebrae 602, extends through a slot 653 a in an identical side block651 a. The side blocks 651 a further include lower and upper knurledsurfaces 652 a, 654 a similar to the knurled surfaces 652, 654 of thespinal plate 651.

This second type of fixation element 650 further includes a rod 658 aextending from the opening 655 a in one side block 651 a to the opening655 a in the other side block 651 a. Set screws 659 a secure the rod 658a in each opening 655 a when the rod 658 a is positioned properly tosecure the vertebrae 601, 602 together, as viewed in FIG. 27.

Four of the side blocks 651 a, one on each side of each vertebra 601,602, and two rods 658 a are used to secure the two vertebrae together.The slots 653 a allow further transverse adjustment so that the sameside block 651 a may be used for different size patients. The rods 658 amay also be cut to fit different sized patients.

The cannula 10, support apparatus 110, and vertebral fixation assembly620 described above may be used to perform an operation which securestwo vertebrae 601, 602 together, such as the posterolateral fusion andscrew placement described above. This type of operation traditionallyresults in much blood loss because of the open access to the spinerequired for its performance. Utilizing the cannula 10 and supportapparatus 110 for placement of the fixation assembly 620 at the surgicalsite and attachment of the fixation assembly 620 to the vertebrae 601,602 in a manner to be described results in a much less invasiveprocedure and significantly less blood loss.

According to one embodiment, a method of fixing the vertebrae 601, 602of a patient together at two surgical sites includes two mainprocedures. In the first procedure, a first cannula 10 is inserted intothe body 130 of the patient adjacent one side of the spinal column. Asecond cannula 10 is inserted into the body 130 of the patient adjacentthe other side of the spinal column. The second tubular portions 40 ofboth cannulae are expanded as described above thereby creating asubstantially complete view of both sides of the two adjacent vertebrae601, 602. In one embodiment, the two adjacent vertebrae 601, 602 areviewed by way of two endoscopes 200 and one or more monitors.

Alternatively, instead of using two cannulae and two endoscopessimultaneously so that both sides of adjacent vertebrae may be worked onby the surgeon at the same time, only one side of the adjacent vertebraemay be worked on and then the other side of the adjacent vertebrae maybe worked on. In this case, only one endoscope, one endoscope support110, and one monitor is required. Two cannulae would most probably beused, one for each side of the vertebrae.

In the second procedure, the vertebrae 601, 602 are accessed through thecannulae 10. Four insertion openings are drilled, one in each side ofeach vertebra 601, 602, utilizing suitable instruments extending throughthe cannulae 10. The fasteners 624 are inserted through each cannulae 10and are screwed one fastener 624 into each insertion opening, therebysecuring each fastener 624 to a vertebra. The position of the vertebrae601, 602 are checked to ensure that the vertebrae have maintained theproper position. If necessary, the vertebrae 601, 602 are repositioned.Eight fixation washers 640, 660, four locking nuts 670, and two fixationelements 650 are moved through the cannulae 10. Four fixation washers640 and the fixation elements 650 are placed on the fasteners 624. Eachfastener 624 is extended through one fixation washer and one slot ineach fixation element 650. The additional fixation washers 660 areplaced on the fasteners 624. The locking nuts 670 are threaded onto eachfastener 624 thereby fixing the fixation elements 650 to the vertebrae601, 602 and securing the vertebrae together in a natural and permanentposition within the body. Also, bone graft may be moved through thecannulae 10 and placed in and around the fixation element 650 andfasteners 624 to permit a posterior fusion across the bony elements ofthe vertebrae 601, 602.

If necessary, the disc between the vertebrae 601, 602 may be removedthrough the cannula; the area between the vertebrae cleaned and thevertebrae prepared for receiving a fusion cage or cages and/or discreplacement material. This would be done before inserting the fasteners624 or attaching the fixation elements 650. The method may also includeinserting, through the cannulae 10, one or more appropriately sizedfusion cages and positioning the fusion cage(s) appropriately relativeto the vertebrae 601, 602; and inserting bone graft tissue through thecannulae 10 and positioning the tissue in and around the fusion cage(s).

The fusion cage may be of any known construction. One typical fusioncage is a hollow rectangular cage that is inserted into grooves that areformed in facing bone surfaces of the vertebrae. Another type of fusioncage is a hollow cylindrical threaded cage which screws into positionbetween the vertebrae. Any suitable fusion cage may be used.

The cannulae 10 and the shrink wrap 102 are then removed from the bodyand the incisions are suitably closed. After a time, vertebrae 601, 602and bone graft will grow together across the fusion cage(s) and in andaround the fixation elements 650. The vertebrae 601, 602 will then nolonger require the fixation assembly to maintain their position. Thefixation elements 650 and fasteners 624 may then be removed. The removalprocedure may utilize the same type of apparatus as was used in thefirst and second procedures (i.e., cannula, support apparatus, etc.).

The first and second cannulae 10 may be shifted slightly in theincisions in the body 130 to desired locations within the incisions atany time during the first and second procedures or the removalprocedure. This is accomplished by changing the position of the supportapparatus 110 by manipulating the arm 301.

The method described above may, and most probably does, involve removalof tissue from the surgical site through the cannula 10. Muscle, fat,and bone may be removed through the cannula 10 to provide a proper viewof the vertebrae 601, 602 at the location to receive the fixationassembly 620. Different tools may be used in the process of removingtissue. These tools may include a burr and/or tissue cutting blades thatare inserted through the cannula 10.

A preferred tissue cutting blade device 710 is shown in FIGS. 30-31. Thedevice 710 has an axis 712 and includes inner and outer cutting tubes740, 750. Each of the inner and outer tubes 740, 750 has openings 741,751 into their interiors. Cutting teeth 745, 755 are located on oppositesides of each opening 741, 751.

The inner tube 740 rotates about the axis 712 relative to the outer tube750 within the outer tube. The inner tube 740 rotates in oppositedirections a predetermined amount equal to one or more revolutions aboutthe axis 712, then rotates in the opposite direction the samepredetermined amount. Thus, the inner tube 740 oscillates about the axis712. As the inner tube 740 oscillates/rotates about the axis 712, thecutting teeth 745, 755 on the inner and outer tubes 740, 750 cut tissue.Alternatively, the inner tube 740 may rotate in one direction (clockwiseor counterclockwise) within the outer tube.

During the cutting of tissue, a saline solution or the like may beforced through the annular space 770 between the inner tube 740 and theouter tube 750 to the surgical site. Suction may be applied in theopening 741 of the inner tube 740 to remove the cut tissue and thesaline solution from the surgical site.

A tubular sheath 760 receives the inner and outer cutting tubes 740,750. The sheath 760 extends along the length of the cutting tubes 740,750 and adjacent a distal end of the cutting tubes where the cuttingteeth 745, 755 are located. The sheath 760 is a stainless steel tubethat is electrically insulated along its length from the patient's bodyand from the outer tube 750. An electrical insulator 763, such as asuitable polymer coating, is provided over the outside and insidesurfaces of the sheath 760. However, a selected area 762 of the outsidesurface of the sheath 760 adjacent the distal end of the cutting tubes740, 750 is not coated with the insulator 763. A portion 765 of thedistal end of the sheath 760 is cut away so that the cutting teeth 745,755 on the cutting tubes 740, 750 are not blocked by the sheath 760 fromcutting tissue.

An electric current from a current source 766 is applied to the sheath760. The electric current flows through the sheath 760 and to theselected uncoated area 762 of the sheath. The current then flows throughtissue and blood into the distal end of the outer cutting tube 750 andback to the current source through the outer cutting tube to form acompleted circuit.

The current flow through the electrically energized sheath 760 and outercutting tube 750 serves to electrocoagulate blood in the cutting area atthe surgical site. Electrocoagulation of blood is known and any othersuitable electrocoagulation device may alternatively be used.

It is contemplated that viewing of the surgical site may be performedwithout using an endoscope. A microscope or glasses that magnify thesite may be used. In fact, any suitable viewing device may be used.Also, the procedure discussed above mentions drilling the vertebrae. Anysuitable alternative to drilling may be used such as using an awl orother instrument to form an opening to receive a fastener.

An exemplary arrangement for performing a procedure in accordance withthe invention is illustrated in FIG. 32. The patient P is typicallyplaced in the prone position on operating table T, taking care that theabdomen is not compressed and physiological lordosis is preserved, as isknown in the art. The physician D is able to access the surgical siteand perform the surgical procedure with the components of a surgicalsystem 1010, which will be described in greater detail herein. Thesystem 1010 may be supported, in part, by a mechanical support arm A,such as the type generally disclosed in U.S. Pat. No. 4,863,133, whichis incorporated by reference in its entirety herein. The mechanical armof this type is manufactured by Leonard Medical, Inc., 1464 HolcombRoad, Huntington Valley, Pa., 19006. The physician D is able to view theprocedure by reference to a monitor M, which displays the imagescaptured by an endoscope and camera which will be described in greaterdetail herein. Alternatively, the physician D may view the surgical sitethough an eyepiece of the endoscope, or she may directly view thesurgical site with loupes, microscope, or with the unaided eye.

The procedure described below is a two level posterolateral fixation ofthe spine involving the L4, L5 and S1 vertebrae. (In the drawings, thevertebrae will generally be denoted by reference letter V.) Theusefulness of the inventive procedure is neither restricted to theposterolateral approach nor to the L4, L5 and S1 vertebrae, but it maybe used in other anatomical approaches and other vertebrae within thecervical, thoracic and lumbar spine. The inventive procedure may bedirected toward surgery involving one or more vertebral levels. It isalso useful for anterior and lateral procedures. Moreover, it isbelieved that the invention is also particularly useful where any bodystructures must be accessed beneath the skin and muscle tissue of thepatient, and where it desirable to provide sufficient space andvisibility in order to manipulate surgical instrumentation and treat theunderlying body structures. For example, certain features orinstrumentation described herein are particularly useful for a minimallyinvasive, e.g., arthroscopic procedures, in which the expandable distalportion of the expandable conduit prevents the instrument fromdislodging or popping out of the operative site.

The system 1010 includes another access device, such as an expandablecannula or conduit which provides an internal passage for surgicalinstrumentation to be inserted through the skin and muscle tissue of thepatient P to the surgical site. The expandable conduit has a wallportion defining reduced profile configuration for initial percutaneousinsertion into the patient. This wall portion may have a generallytubular configuration that may be passed over a dilator that has beeninserted into the patient to atraumatically enlarge an openingsufficiently large to receive the expandable conduit therein.

The wall portion of the expandable conduit is subsequently expanded toan enlarged configuration, by moving against the surrounding muscletissue to at least partially define an enlarged surgical space in whichthe surgical procedures will be performed. In a sense, it acts as itsown dilator. Typically, but not by way of limitation, the distal portionexpands to a greater extent than the proximal portion, since thesurgical procedures are to be performed at the surgical site adjacentthe distal portion thereof.

While in the reduced profile configuration, the expandable conduitdefines a first unexpanded configuration. Thereafter, the expandableconduit enlarges the surgical space defined thereby by engaging thetissue surrounding the conduit and displacing the tissue radiallyoutwardly as the conduit expands. The expandable conduit may besufficiently rigid to displace such tissue during the expansion thereof.The expandable conduit may be resiliently biased to expand from thereduced profile configuration to the enlarged configuration. Inaddition, the conduit may also be manually expanded with surgicalinstrumentation inserted therein, as will be described below. Thesurgical site is at least partially defined by the expanded conduititself. During expansion, the conduit moves from the first overlappingconfiguration to a second overlapping configuration.

In addition to enlargement, the distal end portion of the expandableconduit may be configured for relative movement with respect to theproximal end portion in order to allow the physician to preciselyposition the distal portion at the desired location. This relativemovement also provides the advantage that the proximal portion of theexpandable conduit nearest the physician D may remain substantiallystable during such distal movement. In an exemplary embodiment, thedistal portion is a separate component which is pivotably or movablyattached relative to the proximal portion. Alternatively, the distalportion is flexible or resilient in order to permit such relativemovement.

Another embodiment of the cannula or expandable conduit for use in amethod is illustrated in FIGS. 33-37 and is designated by referencenumber 1020. The expandable conduit 1020 includes a proximal wallportion 1022, which has a tubular configuration, and a distal wallportion, which is an expandable skirt portion 1024. The skirt portion1024 is expandable from a reduced profile configuration having aninitial dimension 1026 and corresponding cross-sectional area(illustrated in FIG. 33), to an enlarged configuration having adimension 1028 and corresponding cross-sectional area (illustrated inFIG. 35). The skirt portion 1024 may be attached to the proximalcylindrical tube portion 1022 with a rivet 1030, pin, or similarconnecting device to permit movement of the skirt portion 1024 relativeto the proximal cylindrical tube portion 1022.

The skirt portion 1024 is manufactured from a resilient material, suchas stainless steel. The skirt 1024 is manufactured so that it normallyassumes an expanded configuration illustrated in FIG. 35. As illustratedin FIG. 34, the skirt portion 1024 may assume an intermediate dimension1034 and corresponding cross-sectional area, which is greater thandimension 1026 of the reduced profile configuration of FIG. 33, andsmaller than dimension 1028 of FIG. 35. Skirt portion 1024 may assumethe configuration of FIG. 34 when deployed in the patient in response tothe force of the tissue acting on the skirt portion. The actualdimension 1034 will depend upon several factors, including the rigidityof the skirt portion 1024, the surrounding tissue, and whether suchsurrounding tissue has relaxed or tightened during the course of theprocedure. An outer plastic sleeve 1032 (illustrated in dashed line inFIG. 33) may be provided which surrounds the expandable conduit 1020 andmaintains the skirt 1024 in the reduced profile configuration. Theplastic sleeve 1032 may have a braided polyester suture embedded withinit (not shown), aligned substantially along the longitudinal axisthereof; such that when the suture is withdrawn, the sleeve 1032 istorn, which allows the expandable conduit 1020 to resiliently expandfrom the reduced profile configuration of FIG. 33 to the expandedconfigurations of FIGS. 34-35. While in the reduced profileconfiguration of FIG. 33, the skirt portion 1024 defines a firstoverlapping configuration 1033, as illustrated by the dashed line. Asthe skirt portion 1024 resiliently expands, the skirt portion assumesthe second configuration 1035, as illustrated in FIGS. 34-35.

The skirt portion 1024 is sufficiently rigid that it is capable ofdisplacing the tissue surrounding the skirt portion as it expands.Depending upon the resistance exerted by surrounding tissue, the skirtportion 1024 is sufficiently rigid to provide some resistance againstthe tissue to remain in the configurations of FIGS. 34-35. Moreover, theexpanded configuration of the skirt portion 1024 is at least partiallysupported by the body tissue of the patient. The rigidity of the skirtportion 1024 and the greater expansion at the distal portion creates astable configuration that is at least temporarily stationary in thepatient, which frees the physician from the need to actively support theconduit 1020 until the endoscope mount platform 1300 and support arm1400 are subsequently added (see FIGS. 52-53).

The skirt portion 1024 of expandable conduit 1020 is illustrated in aninitial flattened configuration in FIG. 36. The skirt portion 1024 maybe manufactured from a sheet of stainless steel having a thickness ofabout 0.007 inches for skirt portions having a fully expanded dimension1028 of about 65 mm in its unrestricted circular shape. The skirtportion 1024 may also take on an oval shape having a longer dimension ofabout 85 mm. An increased thickness, e.g., about 0.010 inches, may beused in connection with skirt portions having a larger diameter, such asabout 65 mm. Other materials, such as Nitinol or plastics having similarproperties, may also be useful.

As discussed above, the skirt portion 1024 is attached to the proximalcylindrical portion 1022 with a pivotable connection, such as rivet1030. A pair of rivet holes 1036 are provided in the skirt portion 1024to receive the rivet 1030. The two free ends 1038 and 1040 of the skirtportion 1024 are secured by a slidable connection, such as second rivet1044 (not shown in FIG. 36, illustrated in FIGS. 33-35). A pair ofcomplementary slots 1046 and 1048 are defined in the skirt portion 1024adjacent the end portions 1038 and 1040. The rivet 1044 is permitted tomove freely within the slots 1046 and 1048. This slot and rivetconfiguration allows the skirt portion 1024 to move between the reducedprofile configuration of FIG. 33 and the expanded configuration of FIGS.34-35. The use of a pair of slots 1046 and 1048 reduces the risk of the“button-holing” of the rivet, i.e., a situation in which the opening ofthe slot becomes distorted and enlarged such that the rivet may slideout of the slot, and cause failure of the device. However, thelikelihood of such occurrence is reduced in skirt portion 1024 sinceeach of the slots 1046 and 1048 in the double slot configuration has arelatively shorter length than a single slot configuration, whichthereby limits the ability of the respective slots 1046 and 1048 to bedistorted to the extent in which a rivet may slide out of position. Inaddition, the configuration of rivet 1044 and slots 1046 and 1048permits a smooth operation of enlarging and reducing the skirt portion1024, and allows the skirt 1024 to expand to span as many as threevertebrae, e.g., L4, L5, and S1, to perform a multi-level fixation.

An additional feature of the skirt 1024 is the provision of a shallowconcave profile 1050 defined along the distal edge of the skirt 1024,which allows for improved placement of the skirt 1024 with respect tothe body structures and the surgical instruments defined herein. Smallscalloped or notched portions 1056 and 1058, are provided, asillustrated in FIG. 36. When the skirt 1024 is assembled, the cut outportions 1056 and 1058 are oriented in the cephalad-caudal direction(indicated by arrow 1060) in FIG. 35 and permit instrumentation, such asan elongated member or fixation element 4650 used in a fixationprocedure to secure vertebrae (described in detail below), to extendbeyond the area enclosed by the skirt portion 1024 without moving orraising the skirt portion 1024 from its location to allow the elongatedmember 4650 to pass under the skirt portion 1024. (In another embodimentof the cannula or expandable conduit 1054 illustrated in FIG. 37, cutout portions 1056 and 1058 are eliminated from the contour where thephysician deems such cut out portions 1056 and 1058 to be unnecessary inview of the spacing of the fasteners 4600 or the length of the elongatedmember 4650.)

As illustrated in FIG. 35, the skirt 1024 may be expanded to asubstantially conical configuration having a substantially circular orelliptical profile. Alternatively, features may be provided on the skirtwhich facilitate the bending of the skirt at several locations toprovide a pre-formed enlarged configuration. For example, in anotherembodiment of the cannula or expandable conduit 1070, illustrated inFIGS. 38-40, skirt portion 1074 may have four sections 1076 a, 1076 b,1076 c, 1076 d having a reduced thickness. For a skirt portion 1074having a thickness 1078 of about 0.007 inches thick, reduced thicknesssections 1076 a, 1076 b, 1076 c, 1076 d may have a thickness 1080 ofabout 0.002-0.004 inches (FIG. 39). The width of the reduced thicknesssections 1076 a, 1076 b, 1076 c, 1076 d may be about 1-5 mm. Thethickness 1078 of the skirt portion 1074 may be reduced by milling orgrinding, as is known in the art. Thus when the skirt 1074 is opened, itmoves toward a substantially rectangular configuration, subject to theresisting forces of the body tissue (FIG. 40). Alternatively, anotherembodiment of the skirt (not shown) may be provided with two reducedthickness sections (rather than the four reduced thickness sections ofskirt 1074) which would produce a substantially “football”-shaped accessarea.

In another embodiment of the cannula or expandable conduit 1080, theskirt portion 1084 is provided with a plurality of perforations 1086, inorder to increase flexibility at the desired locations (FIGS. 41-43).The size and number of perforations 1086 may vary depending upon thedesired flexibility and durability. Alternatively, the skirt may bescored or otherwise provided with a groove or rib in order to facilitatethe bending of the skirt at the desired location.

According to still further embodiments, the cannula or expandableconduit may be provided with one slot. As illustrated in FIG. 44, skirtportion 1094 is provided with slot 1096 and aperture 1098. A rivet (notshown) is stationary with respect to aperture 1098 and slides withinslot 1096. Similarly, skirt 1104 is provided with an aperture 1108 whichreceives a rivet (not shown) which slides within elongated slot 1106(FIG. 45).

An early stage in the process is to determine the access point in theskin of the patient to insert the access conduit. In the exemplaryembodiment, the access point corresponds to the posterior-lateralaspects of the spine. Manual palpation and Anterior-Posterior (AP)fluoroscopy may be used to determine the optimal incision locations. Forthe exemplary procedure, placement of the cannula or expandable conduit1020 is preferably midway (in the cephalad-caudal direction) between theL4 through S1 vertebrae, centrally about 4-7 cm from the midline.

An incision is made at the above-determined location. A guide wire (notshown) is introduced under fluoroscopic guidance through the skin,fascia, and muscle to the approximate surgical site. A series ofdilators is used to sequentially expand the incision to the desiredwidth, about 23 mm for the exemplary procedure, without damaging thestructure of surrounding tissue and muscles. A first dilator is placedover the guide wire, which expands the opening. The guide wire is thensubsequently removed. A second dilator that is slightly larger than thefirst dilator is placed over the first dilator, which expands theopening further. Once the second dilator is in place, the first dilatoris subsequently removed. This process of (1) introducing anext-larger-sized dilator coaxially over the previous dilator and (2)subsequently removing the previous dilator when the next-larger-sizeddilator is in place continues until an opening of the desired size iscreated in the skin, muscle, and subcutaneous tissue. In the exemplarymethod, this dimension is about 23 mm. (Other dimensions of the opening,e.g., about 20 mm, 27 mm, 30 mm, etc., are also useful with thisapparatus in connection with spinal surgery, and still other dimensionsare contemplated.)

As illustrated in FIG. 46, following placement of the largest dilator1120, the expandable conduit 1020, in its reduced profile configuration,is introduced and positioned in a surrounding relationship over thedilator 1120. Dilator 1120 is subsequently removed from the patient, andthe expandable conduit 1020 is allowed to remain in position.

Once the expandable conduit 1020 is positioned in the patient, it may beenlarged to provide a passage for the insertion of various surgicalinstrumentation and an enlarged space for performing the proceduresdescribed herein. As described above, the expandable conduit mayaccommodate the enlargement in several ways. In one embodiment, a distalportion of the cannula may be enlarged, and a proximal portion maymaintain a constant diameter. The relative lengths of the proximalportion 1022 and the skirt portion 1024 may be adjusted to vary theoverall expansion of the conduit 1020. Alternatively, such expansion mayextend along the entire length of the expandable conduit. In theexemplary procedure, the expandable conduit 1020 may be expanded byremoving suture 1035 and tearing sleeve 1032 surrounding the expandableconduit 1020, and subsequently allowing the skirt portion 1024 toresiliently expand towards its fully expanded configuration as(illustrated in FIG. 35) to create an enlarged surgical space from theL4 to the S1 vertebrae. The resisting force exerted on the skirt portionmay result in the skirt portion 1024 assuming the intermediateconfiguration illustrated in FIG. 34. Under many circumstances, thespace created by the skirt portion 1024 in the intermediateconfiguration is a sufficiently large working space to perform theprocedure described herein. Once the skirt portion 1024 has expanded,the rigidity and resilient characteristics of the skirt portion 1024allow the conduit 1020 to resist closing to the reduced profileconfiguration of FIG. 33 and to at least temporarily resist beingexpelled from the incision. These characteristics create a stableconfiguration for the conduit 1020 to remain in position in the body,supported by the surrounding tissue. It is understood that additionalsupport may be needed, especially when an endoscope 1500 is added.

According to the exemplary embodiment, the expandable conduit 1020 maybe further enlarged at its distal end portion using an expanderapparatus to create a surgical access space. An expander apparatususeful for enlarging the expandable conduit has a reduced profileconfiguration and an enlarged configuration. The expander apparatus isinserted into the expandable conduit in the reduced profileconfiguration, and subsequently expanded to the enlarged configuration.The expansion of the expander apparatus also causes the expandableconduit to be expanded to the enlarged configuration. In someembodiments, the expander apparatus may increase the diameter of theexpandable conduit along substantially its entire length in a conicalconfiguration. In other embodiments, the expander apparatus expands onlya distal portion of the expandable conduit, allowing a proximal portionto maintain a constant diameter.

In addition to expanding the expandable conduit, the expander apparatusmay also be used to position the distal portion of the expandableconduit at the desired location for the surgical procedure. The expanderengages the interior wall of the expandable conduit, and moves thecannula to the proper location. For the embodiments in which the distalportion of the expandable conduit is relatively movable with respect tothe proximal portion, the expander apparatus is useful to position thedistal portion without substantially disturbing the proximal portion.

In the exemplary embodiment, an expander apparatus may be used tofurther expand the skirt portion 1024 towards the fully expandedconfiguration (illustrated in FIG. 35). The expander apparatus isinserted into the expandable conduit, and typically has two or moremembers which are movable to engage the interior wall of the skirtportion 1024 and apply a force sufficient to further expand the skirtportion. An exemplary expander apparatus, expander apparatus 1200, isillustrated in FIGS. 47 and 48, and is constructed of two components1202 and 1204 defining a tongs-like configuration, and which arepivotable about a pin 1206. The components 1202 and 1204 are typicallyconstructed of steel having a thickness of about 9.7 mm. Each of thecomponents 1202 and 1204 has a proximal handle portion 1208 and a distalexpander portion 1210. Each proximal handle portion 1208 has a fingergrip 1212 that may extend transversely from the longitudinal axis 1214of the apparatus 1200. The proximal handle portion 1208 may furtherinclude a stop element, such as flange 1216, that extends transverselyfrom the longitudinal axis 1214, and which is dimensioned to provide avisual and tactile indication of the proper depth for inserting theexpander apparatus 1200 by engaging the proximal portion 1025 of theexpandable conduit 1020 when the apparatus 1200 is inserted apredetermined depth. In the exemplary embodiment, the dimension 1218from the flange 1216 to the distal tip 1220 is about 106 mm. Thedimension 1218 is determined by the typical depth of the body structuresbeneath the skin surface at which the surgical procedure is beingperformed. The distal portions 1210 are each provided with afrusto-conical outer surface 1222 for engaging the inside wall of theskirt portion 1024. As illustrated in FIG. 47, the unexpanded distalwidth 1224 of the apparatus 1200 at the distal tip 1220 is about 18.5mm.

In use, the finger grips 1212 are approximated towards one another(arrow A), which causes the distal portions 1210 to move to the enlargedconfiguration (arrows B), illustrated in FIG. 48. The components 1202and 1204 are also provided with a cooperating tab 1226 and shoulderportion 1228 which are configured for mutual engagement when the distalportions 1210 are in the expanded configuration. In the exemplaryembodiment, the expanded distal width 1230 of the distal portions 1210is about 65 mm to about as large as 83 mm. The tab 1226 and shoulderconfiguration 1228 limits the expansion of the apparatus 1200 in orderto prevent expanding the skirt portion 1024 of the expandable conduit1020 beyond its designed dimension, and to minimize trauma to theunderlying tissue. Further details of the expander apparatus aredescribed in U.S. patent application Ser. No. 09/906,463 filed Jul. 16,2001, which is incorporated by reference in its entirety herein.

When the expandable conduit 1020 is inserted into the patient and sleeve1032 is removed, the skirt portion 1024 expands to a point where theoutward resilient expansion of the skirt portion is balanced by theforce of the surrounding tissue. The surgical space defined by theconduit may be sufficient to perform the surgical procedures. However,if it is desired to expand the expandable conduit 1020 further, theexpander apparatus 1200 may be inserted into the expandable conduit 1020in the reduced profile configuration until the shoulder portions 1216are in approximation with the proximal lip 1025 of the cylindricalportion 1024 of the expandable conduit 1020 (FIG. 49).

As illustrated in FIG. 49, the expander apparatus 1200 is inserted inthe access conduit 1020 in the reduced profiled configuration. Expansionof apparatus 1200 is achieved by approximating the handle portions 1212(not shown in FIG. 50), which causes the distal portions 1210 of theexpander apparatus 1200 to move to a spaced apart configuration. As thedistal portions 1210 move apart and contact the inner wall of the skirtportion 1024, it is expanded by allowing the floating rivet 1044 toslide within the two slots 1046 and 1048 of the skirt portion 1024. Whenthe distal portions 1210 reach the maximum expansion of the skirtportion 1024 (illustrated by a dashed line), the shoulder 1228 and tabportion 1226 of the expander apparatus 1200 come into engagement toprevent further expansion of the tong portions (as illustrated in FIG.48). The conduit 1020 may be alternatively further expanded with aballoon or similar device.

A subsequent, optional step in the procedure is to adjust the locationof the distal portion of the expandable conduit relative to the bodystructures to be operated on. For example, the expander apparatus 1200may also be used to engage the inner wall of the skirt portion 1024 ofthe expandable conduit 1020 in order to move the skirt portion 1024 ofthe expandable conduit 1020 to the desired location. For an embodimentin which the skirt portion 1024 of the expandable conduit 1020 isrelatively movable relative to the proximal portion, e.g. by use of therivet 1030, the expander apparatus 1200 is useful to position the skirtportion 1024 without substantially disturbing the proximal portion 1022or the tissues closer to the skin surface of the patient. As will bedescribed below, the ability to move the distal end portion, e.g., theskirt portion, without disturbing the proximal portion is especiallybeneficial when additional apparatus, as described below, is mountedrelative to the proximal portion of the expandable conduit.

An endoscope mount platform 1300 and indexing arm 1400 providesecurement of an endoscope 1500 on the proximal portion 1025 of accessconduit 1020 for remotely viewing the surgical procedure, as illustratedin FIGS. 51-54. The endoscope mount platform 1300 also provides severalfunctions during the surgical procedure. The endoscope mount platform1300 includes a base 1302 that extends laterally from a central opening1304 in a general ring-shaped configuration. For the physician who isprimarily viewing the procedure by observing a monitor, the base 1302provides an aid for the physician when inserting surgical instrumentsinto the central opening 1304. For example, the size of the base 1302provides visual assistance (as it may be observable in the physician'speripheral vision) as well as provides tactile feedback as theinstruments are lowered towards the central opening 1304 and into theexpandable conduit 1020.

The endoscope mount platform 1300 further provides a guide portion 1306,which extends substantially parallel to the longitudinal axis 1308 awayfrom the central opening 1304. The base 1302 is typically molded as onepiece with the guide portion 1306. The base 1302 and guide portion 1306may be constructed as a suitable polymer such as polyetheretherketone(PEEK).

The guide portion 1306 includes a first upright member 1310 extendingupward from the base 1302, and a second upright member 1312 extendingupward from the base 1302. The upright members 1310 and 1312 each have arespective vertical grooves 1314 and 1315 for slidably receiving anendoscopic mount assembly 1318.

The endoscope 1500 (not shown in FIG. 51) is movably mounted to theendoscope mount platform 1300 by the endoscope mount assembly 1318including endoscope mount 1320 and a saddle unit 1322. The saddle unit1322 is slidably mounted within the grooves 1314 and 1315 in the uprightmembers 1310 and 1312. The endoscope mount 1320 receives the endoscope1500 through a bore 1326 which passes through the endoscope mount 1320.Part of the endoscope 1500 may extend through the expandable conduit1020 substantially parallel to central axis 1308 into the patient's body1130.

The endoscope mount 1320 is removably positioned in a recess 1328defined in the substantially “U”-shaped saddle unit 1322, which isselectively movable in a direction parallel to the longitudinal axis1308 in order to position the endoscope 1500 at the desired heightwithin the expandable conduit 1020 to provide a zoom feature tophysician's view of the surgical procedure.

A screw mechanism 1340 is positioned on the base 1302 and between theupright members 1310 and 1312, and is used to selectively move thesaddle unit 1322 with the endoscope mount 1320 and the endoscope 1500.The screw mechanism 1340 comprises a thumb wheel 1342 and a spindle1344. The thumb wheel 1342 is rotatably mounted in a bore in the base1302. The thumbwheel has an external thread 1346 received in acooperating thread in the base 1302. The spindle 1344 is mounted formovement substantially parallel to the central axis 1308. The spindle1344 has a first end received in a rectangular opening in the saddleunit 1322, which inhibits rotational movement of the spindle unit 1344.The second end of the spindle 1344 has an external thread whichcooperates with an internal thread formed in a bore within thethumbwheel 1342. Rotation of the thumb wheel 1342 relative to thespindle 1344, causes relative axial movement of the spindle unit 1344along with the saddle unit 1322. Further details of the endoscope mountplatform are described in U.S. patent application Ser. No. 09/491,808,filed Jan. 28, 2000, now U.S. Pat. No. 6,361,488, application Ser. No.09/821,297, filed Mar. 29, 2001, now U.S. Pat. No. 6,530,880, andapplication Ser. No. 09/940,402, filed Aug. 27, 2001, and published asPublication No. 2003/0040656, all of which are incorporated by referencein their entirety herein.

As illustrated in FIGS. 52-54, the endoscope mount platform 1300 ismounted to the support arm 1400. The support arm 1400, in turn, ismounted to mechanical support, such as mechanical support arm A. Thesupport arm 1400 rests on the proximal portion 1025 of the expandableconduit 1020. The support arm 1400 includes an indexing collar 1420,which is received in the central opening 1304 of the base 1302 ofendoscope mount platform 1300. The indexing collar 1420 is substantiallytorroidal in section and has an outer peripheral wall 1422 and innerwall 1424 and a wall thickness 1426. The indexing collar furtherincludes a flange 1428, which supports the indexing collar 1420 on thesupport arm 1400.

In order to support cannula or conduits 1020 of different dimensions, aplurality of indexing collars 1420 may be provided to accommodate eachrespective conduit size while using a single endoscope mount platform1300. The central opening 1304 of the endoscope mount platform 1300 hasconstant dimension, e.g., a diameter of about 32.6 mm. An appropriateindexing collar 1420 is selected to support the respective conduit 1020.Thus the outer wall 1422 and the outer diameter 1430 are unchangedbetween different indexing collars 1420, although the inner wall 1424and the inner diameter 1432 vary to accommodate differently sizedconduits 1020.

The indexing collar 1420 is mounted to the proximal portion of theexpandable conduit 1020 and allows angular movement of the endoscopemount platform 1300 with respect thereto about the central axis 1308 (asindicated by arrow C in FIG. 52). The outer wall 1422 of the indexcollar 1420 includes a plurality of hemispherical recesses 1450 forreceiving one or more ball plungers 1350 on the endoscope mount platform1300 (indicated in dashed line.) This mount configuration permits theendoscope mount platform 1300, along with the endoscope 1500 to be fixedin a plurality of discrete angular positions. Further details of thesupport arm and indexing collar are described in U.S. patent applicationSer. No. 09/491,808, filed Jan. 28, 2000, now U.S. Pat. No. 6,361,488,application Ser. No. 09/821,297, filed Mar. 29, 2001, now U.S. Pat. No.6,530,880, and application Ser. No. 09/940,402, filed Aug. 27, 2001, andpublished as Publication No. 2003/0040656, all of which are incorporatedby reference hereinabove.

The endoscope, such as endoscope 1500 (FIG. 55), has an elongatedconfiguration that extends into the expandable conduit 1020 in order toview the surgical site. In particular, endoscope 1500 has an elongatedrod portion 1502 and a body portion 1504 which is substantiallyperpendicular thereto. In the exemplary embodiment, rod portion 1502 ofendoscope 1500 has a diameter of about 4 mm and a length of about 106mm. Body portion 1504 may define a tubular portion 1506 which isconfigured to be slidably received in the bore 1326 of endoscope mount1320 as indicated by arrow D. The slidable mount of the endoscope 1500on the endoscope mount 1300 permits the endoscope 1500 to adjust toconfigurations that incorporate different conduit diameters. Additionalmobility of the endoscope 1500 in viewing the surgical site may beprovided by rotating the endoscope mount platform 1300 about the centralaxis 1308 (as indicated by arrow C in FIG. 52).

The rod portion 1502 supports an optical portion (not shown) at a distalend 1508 thereof, which may define a field of view of about 105 degreesand a direction of view 1511 of about 25-30 degrees. An eyepiece 1512 ispositioned at an end portion of the body portion 1504. The camera (notshown) is attached to the endoscope 1500 adjacent the eyepiece 1512 witha standard coupler unit. A light post 1510 supplies illumination to thesurgical site at the distal end portion 1508. A preferred camera for usein the system and procedures described herein is a three chip unit thatprovides greater resolution to the viewed image than a single chipdevice.

A subsequent stage in the procedure is the placement of the support arm1400 and the endoscope mount platform 1300 on the proximal portion 1025of the expandable conduit 1020 (FIG. 53), and mounting of the endoscope1500 on the endoscope mount platform 1300. A next step is insertion ofsurgical instrumentation into the expandable conduit to perform thesurgical procedure on the body structures at least partially within theoperative space defined by the expanded portion of the expandableconduit. In the exemplary method, skirt portion 1024 of expandableconduit 1020 at least partially defines operative space 1090 in whichthe surgical procedures described herein may be performed (FIG. 56).Depending upon the overlap of the skirt portion, the skirt portion maydefine a surface which is continuous about the circumference or which isdiscontinuous having one or more gaps where the material of the skirtportion does not overlap. For illustrative purposes, the surgicalinstrumentation described herein is useful to perform a two-level spinalfixation. Surgical instrumentation inserted into the expandable conduitis used for debridement and decortication. In particular, the softtissue, such as fat and muscle, covering the vertebrae are removed inorder to allow the physician to visually identify the various“landmarks,” or vertebral structures, which enable the physician tolocate the location for attaching the fasteners 4600 or otherprocedures, as will be described herein. Allowing visual identificationof the vertebral structures enables the physician to perform theprocedure while viewing the surgical area through the endoscope,microscope, loupes, etc., or in a conventional, open manner.

Tissue debridement and decortication of bone are completed using one ormore debrider blades, bipolar sheath, high speed burr, and additionalconventional manual instruments. The debrider blades are used to excise,remove and aspirate the soft tissue. The bipolar sheath is used toachieve hemostasis through spot and bulk tissue coagulation. Thedebrider blades and bipolar sheath are described in greater detail inU.S. Pat. No. 6,193,715, assigned to Medical Scientific, Inc., which isincorporated by reference in its entirety herein. The high speed burrand conventional manual instruments are also used to continue to exposethe structure of the vertebrae.

FIGS. 57-61 illustrate an embodiment of a fusion device or spinalimplant 2010 that is inserted between the adjacent vertebrae. The spinalimplant 2010 is placed between adjacent vertebrae to provide sufficientsupport to allow fusion of the adjacent vertebrae, as shown in FIGS. 67and 68. The spinal implants 2010 are preferably made from an allograftmaterial.

The spinal implant 2010 (FIGS. 57-61) has a first end 2020 for insertionbetween the adjacent vertebrae V. The first end 2020 has a taperedsurface 2022 to facilitate insertion of the implant between the adjacentvertebrae V. The surface 2022 defines an angle X of approximately 45° asshown in FIG. 60.

The spinal implant 2010 (FIGS. 57 and 58) has a second end 2030 that isengageable with a tool 2032 (FIG. 70) for inserting the implant betweenthe adjacent vertebrae V. The tool 2032 has a pair of projections 2034,one of which is shown in FIG. 70, that extend into recesses 2036 and2038 in the end 2030 of the implant 2010. The recesses 2036 and 2038(FIGS. 57 and 58) extend from the second end 2030 toward the first end2020. The recess 2036 (FIG. 60) is defined by an upper surface 2040 anda lower surface 2042 extending generally parallel to the upper surface2040. The recess 2038 (FIG. 58) has a lower surface 2046 and an uppersurface 2048 extending generally parallel to the lower surface 2046.

The recesses 2036 and 2038 define a gripping portion 2052. Theprojections 2034 on the tool 2032 extend into the recesses 2036 and 2038and grip the gripping portion 2052. The projections 2034 engage theupper and lower surfaces 2040 and 2042 of the recess 2036 and the upperand lower surfaces 2046 and 2048 of the recess 2038. Accordingly, thetool 2032 grips the implant 2010 for inserting the implant between theadjacent vertebrae V.

The implant 2010 (FIGS. 57-60) has an upper surface 2060, as viewed inFIGS. 57-60, for engaging the upper vertebra V. The implant 2010 has alower surface 2062, as viewed in FIGS. 57-60, for engaging the lowervertebra V. The upper and lower surfaces 2060 and 2062 extend from thefirst end 2020 to the second end 2030 of the implant 2010 and parallelto the upper and lower surfaces 2040, 2042, 2046, and 2048 of therecesses 2036 and 2038. The upper surface 2060 has teeth 2064 forengaging the upper vertebra V. The lower surface 2062 has teeth 2066 forengaging the lower vertebra V. Although FIGS. 57 and 58 show four teeth2064 and four teeth 2066, it is contemplated that any number of teethcould be used.

A first side surface 2070 and a second side surface 2072 extend betweenthe upper and lower surfaces 2060 and 2062. The first side surface 2070extends along a first arc from the first end 2022 of the implant 2010 tothe second end 2030. The second side surface 2072 extends along a secondarc from the first end 2022 to the second end 2030. The first and secondside surfaces 2070 and 2072 are concentric and define portions ofconcentric circles. The teeth 2064 and 2066 parallel to each other andextend between the side surfaces 2070 and 2072 and along secant lines ofthe concentric circles defined by the side surfaces.

The implant 2010 is formed by harvesting allograft material from afemur, as known in the art. The femur is axially cut to form cylindricalpieces of allograft material. The cylindrical pieces are then cut inhalf to form semi-cylindrical pieces of allograft material. Thesemi-cylindrical pieces of allograft material are machined into thespinal implants 2010.

A pair of spinal implants 2010 may be placed bilaterally between theadjacent vertebrae V. The cannula or expandable conduit 1020 is insertedinto the patient's body adjacent the vertebrae V. The skirt portion 1024of the cannula 1020 is radially expanded to provide a working spaceadjacent the vertebrae V. Disc material between the vertebrae V isremoved using instruments such as kerrisons, rongeurs, or curettes. Amicrodebrider may also be utilized to remove the disc material. Anosteotome, curettes, and scrapers are used to prepare end plates of thevertebrae V for fusion. Preferably, an annulus of the disc is leftbetween the vertebrae V.

Distracters are used to sequentially distract the disc space until thedesired distance between the vertebrae V is achieved. The fusion deviceor implant 2010 is placed between the vertebrae V using the tool 2032.The first end 2020 of the implant 2010 is inserted first between thevertebrae V. The implant 2010 is pushed between the vertebrae V untilthe end 2030 of the implant is between the vertebrae. A second spinalimplant 2010 is inserted on the ipsilateral side using the sameprocedure.

A shield apparatus 3100 with an elongated portion 3102 may be used tofacilitate insertion of the implants 2010 between the vertebrae V. Adistal portion 3110 of the apparatus 3100 may be placed in anannulotomy. The implant 2010 is inserted with the side surface 2170facing the elongated portion 3102 so that the apparatus 3100 can act asa “shoe horn” to facilitate or guide insertion of the implants 2010between the vertebrae.

The implants 2010 may be inserted between the vertebrae V with the firstends 2020 located adjacent each other and the second ends 2030 spacedapart from each other, as shown in FIG. 67. The implants 2010 may alsobe inserted between the vertebrae V with the first ends 2020 of theimplants 2010 spaced apart approximately the same distance that thesecond ends 2030 are spaced apart. It is contemplated that the implants2010 may be inserted in any desired position between the vertebrae V. Itis also contemplated that only one implant 2010 may be inserted betweenthe vertebrae V. Furthermore, it is contemplated that the implants 2010may be inserted between vertebrae using an open procedure.

Another embodiment of a fusion device or spinal implant 2110 isillustrated in FIGS. 62-66. The spinal implant 2110 is substantiallysimilar to the embodiment disclosed in FIGS. 57-61. The implant 2110 isplaced between the adjacent vertebrae V to provide sufficient support toallow fusion of the adjacent vertebrae, as shown in FIG. 69. The spinalimplant 2110 is preferably made from an allograft material.

The spinal implant 2110 (FIGS. 62-66) has a first end 2120 for insertionbetween the adjacent vertebrae V. The first end 2120 has a taperedsurface 2122 to facilitate insertion of the implant between the adjacentvertebrae V. The surface 2122 defines an angle Y of approximately 45° asshown in FIG. 65.

The spinal implant 2110 (FIGS. 62 and 63) has a second end 2130 that isengageable with the projections 2034 on the tool 2032 for inserting theimplant between the adjacent vertebrae V. The projections 2034 extendinto recesses 2136 and 2138 in the end 2130 of the implant 2110. Therecesses 2136 and 2138 extend from the second end 2130 toward the firstend 2120. The recess 2136 (FIGS. 62 and 65) is defined by an uppersurface 2140 and a lower surface 2142 extending generally parallel tothe upper surface 2140. The recess 2138 (FIG. 63) has a lower surface2146 and an upper surface 2148 extending generally parallel to the lowersurface 2146.

The recesses 2136 and 2138 define a gripping portion 2152. Theprojections 2034 on the tool 2032 extend into the recesses 2136 and 2138and grip the gripping portion 2152. The projections 2034 engage theupper and lower surfaces 2140 and 2142 of the recess 2136 and the upperand lower surfaces 2146 and 2148 of the recess 2138. Accordingly, thetool 2032 grips the implant 2110 for inserting the implant between theadjacent vertebrae V.

The implant 2110 (FIGS. 62-65) has an upper surface 2160, as viewed inFIGS. 62-65, for engaging the upper vertebra V. The implant 2110 has alower surface 2162, as viewed in FIGS. 62-65, for engaging the lowervertebra V. The upper and lower surfaces 2160 and 2162 extend from thefirst end 2120 to the second end 2130 of the implant 2110 and parallelto the upper and lower surfaces 2140, 2142, 2146, and 2148 of therecesses 2136 and 2138. The upper surface 2160 has teeth 2164 forengaging the upper vertebra V. The lower surface 2162 has teeth 2166 forengaging the lower vertebra V. Although FIG. 63 shows four teeth 2164and four teeth 2166, it is contemplated that any number of teeth couldbe used.

A first side surface 2170 and a second side surface 2172 extend betweenthe upper and lower surfaces 2160 and 2162. The first side surface 2170extends along a first arc from the first end 2122 of the implant 2110 tothe second end 2130. The second side surface 2172 extends along a secondarc from the first end 2120 to the second end 2130. The first and secondside surfaces 2170 and 2172 are concentric and define portions ofconcentric circles. The teeth 2164 and 2166 extend parallel to eachother and between the side surfaces 2170 and 2172 along secant lines ofthe concentric circles defined by the side surfaces.

The implant 2110 is formed by harvesting allograft material from afemur, as is known in the art. The femur is axially cut to formcylindrical pieces of allograft material. The cylindrical pieces arethen cut in half to form semi-cylindrical pieces of allograft material.The semi-cylindrical pieces of allograft material are machined into thespinal implants 2110.

A spinal implant 2110 is placed unilaterally between the adjacentvertebrae V. The cannula 1020 is inserted into the patient's bodyadjacent the vertebrae V. The skirt portion 1024 of the cannula 1020 isradially expanded to provide a working space adjacent the vertebrae V.Disc material between the vertebrae V is removed using instruments suchas kerrisons, rongeurs, or curettes. A microdebrider may also beutilized to remove the disc material. An osteotome, curettes, andscrapers are used to prepare end plates of the vertebrae V for fusion.Preferably, an annulus of the disc is left between the vertebrae V.

Distracters are used to sequentially distract the disc space until thedesired distance between the vertebrae V is achieved. The implant 2110is placed between the vertebrae V using the tool 2032. It iscontemplated that the apparatus 3100 could be used also. The first end2120 of the implant 2110 is inserted first between the vertebrae V. Theimplant 2110 is pushed between the vertebrae V until the end 2130 of theimplant is between the vertebrae. It is contemplated that the implant2110 may be inserted in any desired position between the vertebrae V. Itis also contemplated that more than one implant 2110 may be insertedbetween the vertebrae.

The apparatus or shield 3100 for use in placing the fusion devices orspinal implants between the vertebrae is illustrated in FIGS. 71-75. Theapparatus 3100 includes an elongated body portion 3102, which protectsthe nerve root or dura, and a mounting portion 3104, which allows forthe surgeon to releasably mount the apparatus 3100 to the cannula 1020.Consequently, the surgeon is able to perform the surgical procedureswithout requiring the surgeon or an assistant to continue to support theapparatus 3100 throughout the procedure, and without reducing the fieldof view.

The apparatus 3100 may be manufactured from a biocompatible materialsuch as, but not limited to, stainless steel. In the exemplaryembodiment, apparatus 3100 is manufactured from stainless steel having athickness of about 0.02 inches to about 0.036 inches. The elongated bodyportion 3102 has dimensions which correspond to the depth in the body inwhich the procedure is being performed, and to the size of the bodystructure which is to be shielded by elongated body portion 3102. In theexemplary embodiment, the elongated body portion 3102 has a width 3106of about 0.346 inches and a length of about 5.06 inches (FIG. 72),although other dimensions would be appropriate for spinal surgicalprocedures performed at different locations, or for surgical proceduresinvolving different body structures. The distal tip portion 3110 of theapparatus 3100 may have a slightly curved “bell mouth” configurationwhich allows for atraumatic contact with a body structure, such as anerve. It is contemplated that the elongated body portion may have anydesired shape.

The mounting portion 3104 allows the apparatus 3100 to be secured to asupport structure in any number of ways. In the exemplary embodiment,mounting portion 3104 may include a ring portion. With reference toFIGS. 71-75, ring portion 3120 has a substantially ring-shapedconfiguration with an opening 3124, which defines an angle 3126 of about90 degrees of the total circumference of the ring portion 3120. As willbe described in greater detail below, the angle 3126 is a nominal value,because the ring portion 3104 is resilient, which permits the opening3124 to change size during the mounting process.

In the exemplary embodiment, the mounting portion 3104 has asubstantially cylindrical configuration in order to be mounted withinthe interior lumen of the cannula 1020, as will be described below. Thering portion 3104 has an exterior dimension 3130 of about 0.79 inches,and an interior dimension 3132 of about 0.76 inches. It is understoodthat the dimensions of the ring portion 3104 would be different if theexpandable conduit 1020 has a different interior dimension. Moreover,the cylindrical shape of the ring portion 3104 would change if theapparatus 3100 is used with a support member having a differently shapedinternal lumen.

Finger grip portions 3122 extend from the mounting portion 3104 andallow the surgeon to apply an inwardly directed force (as indicated byarrows A) to the ring portion 3120. The resilient characteristics of thering portion 3120 allow the material to deflect thereby reducing theexterior dimension 3130 and reducing the spacing 3124. Releasing thefinger grip portions 3122 allows the ring portion to move towards itsundeflected condition, thereby engaging the interior wall of theexpandable conduit 1020.

The elongated body portion 3102 and the mounting portion 3104 may bemanufactured from a single component, such as a sheet of stainlesssteel, and then the mounting portion 3104 may be subsequently formedinto a substantially cylindrical shape. In another embodiment, themounting portion 3104 may be manufactured as a separate component andattached to the elongated body portion, by techniques such as, but notlimited to welding and securement by fasteners, such as rivets.

The expandable conduit 1020 serves as a stable mounting structure forapparatus 3100. In particular, mounting portion 3104 is releasablymounted to the interior wall of proximal wall portion 1022 of expandableconduit 1020. Elongated body portion 3102 extends distally into theoperative site to protect the desired body structure, such as the nerve,as will be described below.

To install the apparatus 3100 within the interior passage of theproximal wall portion 1022, the surgeon may apply an inwardly directedforce on the ring portion 3120, thereby causing the ring portion toresiliently deform, as illustrated by dashed line and arrows B in FIG.78. The surgeon subsequently inserts the apparatus 3100 into theinterior lumen of the proximal wall portion 1022 (as indicated by arrowC) to the position of ring portion 3104 illustrated in solid line inFIG. 77. When the surgeon releases the finger grip portions 3122, thering portion 3120 resiliently moves towards its undeflectedconfiguration, thereby engaging the interior lumen of the proximal wallportion 1022. The mounting portion 3104 described herein has theadvantage that it is easily removed and/or moved with respect to theconduit 1020 without disturbing the position of the conduit 1020 or anyother instrumentation.

As illustrated in FIG. 76, the configuration of the mounting portion3104 and the elongated body portion 3102 allow the elongated bodyportion to occupy a small space along the periphery of the proximal wallportion 3122. This allows the apparatus to protect the desired bodystructure without blocking access for the insertion of other surgicalinstrumentation, and without blocking visibility by the surgeon duringthe procedure.

The mounting portion 3104 is one exemplary configuration for mountingthe apparatus 3100 to the support structure. It is contemplated that theapparatus 3100 may be-mounted within the cannula in another manner.

When in position, the distal end portion 3110 covers the exiting nerveroot R, while exposing the disc annulus A (See FIG. 76). As discussedabove, the debridement and decortication of tissue covering thevertebrae, as well as a facetecomy and/or laminectomy if indicated, areperformed prior to the insertion of apparatus 3100 into the surgicalspace. Thus, there is no need to displace or retract tissue, andapparatus 3100 merely covers the nerve root and does not substantiallydisplace the nerve root or any other body tissue. It is understood thatterm “cover” as used herein refers to apparatus 3100 being a smalldistance adjacent to the body structure, or in contact with the bodystructure without applying significant tension or displacement force tothe body structure.

Additional surgical instrumentation S may be inserted into theexpandable conduit to perform procedures on the surrounding tissue. Forexample, an annulotomy may be performed using a long handled knife andkerrisons. A discectomy may be completed by using curettes and rongeurs.Removal of osteophytes which may have accumulated between the vertebraemay be performed using osteotomes and chisels.

As illustrated in FIG. 79, the elongated body portion 3102 is rotated toprotect the spinal cord, or dura D, during the above procedures. Thesurgeon may change the position of the apparatus 3100 by approximatingthe finger grips 3122 to release the ring portion from engagement withthe inner wall of the proximal wall portion 1020, and then re-positionthe apparatus 3100 without disturbing the expandable conduit 1020 (asshown in FIG. 77).

During certain surgical procedures, it may be useful to introducecrushed bone fragments or the fusion devices 2010 or 2110 to promotebone fusion. As illustrated in FIGS. 80-80 a, apparatus 3100 is usefulto direct the implants into the space I between adjacent vertebrae V. Asshown in the figures, the distal portion 3110 of the elongated bodyportion 3102 is partially inserted into the space I. The distal endportion 3110, is positioned between adjacent vertebrae V, and creates apartially enclosed space for receiving the implants or other materialtherein.

Another embodiment of the apparatus or shield is illustrated in FIGS.81-82, and designated apparatus 3200. Apparatus 3200 is substantiallyidentical to apparatus 3100, described above, with the followingdifferences noted herein. In particular, distal end portion 3210includes a pair of surfaces 3240 and 3242. Surface 3240 is an extensionof elongated shield portion 3202, and surface 3242 extends at an anglewith respect to surface 3240. In the exemplary embodiment, surfaces 3240and 3242 defined an angle of about 90 degrees between them.Alternatively another angle between surfaces 3240 and 3242 may bedefined as indicated by the body structures to be protected.

Distal end portion 3210 allows the apparatus to provide simultaneousshielding of both the dura D and the nerve root R. In FIGS. 83-84,surface 3242 shields the dura D, and surface 3240 shields the nerve rootR. It is understood that surfaces 3240 and 3242 may be interchanged withrespect to which tissue they protect during the surgical procedure.

After the spinal implants 2010 or 2110 are inserted between thevertebrae V, the fasteners 4600 are attached to the vertebrae. Prior toattachment of the fasteners, the location of the fastener attachment isconfirmed. In the exemplary embodiment, the pedicle entry point of theL5 vertebra is located using visual landmarks as well as lateral and A/Pfluoroscopy, as is known in the art. With reference to FIG. 56, theentry point 4092 is prepared with an awl 4550. The pedicle hole 4092 iscompleted using instruments known in the art such as a straight boneprobe, a tap, and a sounder. The sounder, as is known in the art,determines whether the hole that is made is surrounded by bone on allsides, and that there has been no perforation of the pedicle wall.

After hole 4092 in the pedicle is provided (or at any point during theprocedure), an optional step is to adjust the location of the distalportion 1024 of the expandable conduit 1020. This may be performed byinserting the expander apparatus 1200 into the expandable conduit 1020,expanding the distal portions 1210, and contacting the inner wall of theskirt portion 1024 to move the skirt portion 1024 to the desiredlocation. This step may be performed while the endoscope 1500 ispositioned within the expandable conduit 1020, and without substantiallydisturbing the location of the proximal portion of the expandableconduit 1020 to which the endoscope mount platform 1300 may be attached.

A particularly useful fastener for use in the exemplary procedure is thefastener 4600, illustrated in FIGS. 85-86, and described in greaterdetail in U.S. patent application Ser. No. 10/075,668, filed Feb. 13,2002 and in application Ser. No. 10/087,489, filed Mar. 1, 2002, whichare hereby incorporated by reference in their entirety herein. Fastener4600 includes a screw portion 4602, a housing 4604, a spacer member4606, a biasing member 4608, and a clamping member, such as cap screw4610. The screw portion 4602 has a distal threaded portion 4612 and aproximal, substantially spherical joint portion 4614. The threadedportion 4612 is inserted into the hole 4092 in the vertebrae, as will bedescribed below. The substantially spherical joint portion 4614 isreceived in a substantially annular, part spherical recess 4616 in thehousing 4604 in a ball and socket joint relationship (see also FIG. 88).

As illustrated in FIG. 86, the fastener is assembled by inserting thescrew portion 4602 into a bore in a passage 4618 in the housing 4604,until the joint portion 4614 engages the annular recess 4616. The screwportion 4602 is retained in the housing 4604 by the spacer member 4606and biasing member 4608. The biasing member 4608 provides a biasingforce to drive the spacer member 4606 in frictional engagement with thejoint portion 4614 of the screw member 4602 and the annular recess 4616of the housing 4604. The biasing provided by the biasing member 4608frictionally maintains the relative positioning of the housing 4604 withrespect to the screw portion 4602. The biasing member 4608 is selectedsuch that biasing force prevents unrestricted movement of the housing4604 relative to the screw portion 4602. However, the biasing force isinsufficient to resist the application of force by a physician to movethe housing 4604 relative to the screw portion 4602. In other words,this biasing force is strong enough to maintain the housing 4604stationary relative to the screw portion 4602, but this force may beovercome by the physician to reorient the housing 4604 with respect tothe screw member 4602, as will be described below.

In the exemplary embodiment, the biasing member 4608 is a resilient ringhaving a gap 4620, which permits the biasing member 4608 to radiallycontract and expand. The biasing member 4608 has an arched shape, whenviewed end-on (FIG. 86 a). The arch shape of the spring member 4608provides the biasing force, as will be described below. The spacermember 4606 and the biasing member 4608 are inserted into the housing4604 by radially compressing the biasing member into an annular groove4622 in the spacer member 4606. The spacer member 4606 and the biasingmember 4608 are slid into the passage 4618 until the distal surface ofthe spacer member 4606 engages the joint portion 4614 of the screwportion 4602, and the biasing member 4608 expands radially into theannular groove 4620 in the housing 4604. The annular groove 4620 in thehousing 4604 has a dimension 4623 which is smaller than the uncompressedheight of the arched shape of the biasing member 4608. When the biasingmember 4608 is inserted in the annular groove 4620, the biasing member4608 is flattened against its normal bias, thereby exerting the biasingforce to the spacer member 4606. It is understood that similar biasingmembers, such as coiled springs, belleville washers, or the like may beused to supply the biasing force described herein.

The spacer member 4606 is provided with a longitudinal bore 4626, whichprovides access to a hexagonal recess 4628 in the proximal end of thejoint portion 4614 of the screw member 4602. The proximal portion of thehousing 4604 includes a pair of upright members 4630 and 4631 that areseparated by substantially “U”-shaped grooves 4632. A recess forreceiving elongated member 4650 is defined by the pair of grooves 4632between upright members 4630 and 4631. Elongated member 4650 is to beplaced distally into the housing 4604 in an orientation substantiallytransverse to the longitudinal axis of the housing 4604, as will bedescribed below. The inner walls of the upright members 4630 and 4631are provided with threads 4634 for attachment of the cap screw 4610 bythreads 4613 therein.

The fastener 4600 is inserted into the expandable conduit 1020 andguided to the prepared hole 4092 in the vertebrae as a further stage ofthe procedure. The fastener 4600 must be simultaneously supported androtated in order to be secured in hole 4092. In the exemplaryembodiment, the fastener 4600 is supported and attached to the bone byan endoscopic screwdriver apparatus 4660, illustrated in FIG. 87.Screwdriver 4660 includes a proximal handle portion 4662 (illustrated indashed line), an elongated body portion 4664, and a distal tool portion4666.

The distal tool portion 4666, as illustrated in greater detail in FIG.88 includes a substantially hexagonal outer periphery which is receivedin the substantially hexagonal recess 4628 in the joint portion 4614 ofthe screw member 4602. A spring member at the distal tool portion 4666releasably engages the hexagonal recess 4628 of the screw member 4602 tosupport the fastener 4600 during insertion and tightening. In theexemplary embodiment, a spring member 4672 is configured to engage theside wall of the recess 4628. More particularly, a channel/groove isprovided in the tip portion 4666 for receiving the spring member 4672.The channel/groove includes a medial longitudinal notch portion 4676, aproximal, angled channel portion 4678, and a distal substantiallytransverse channel portion 4680. The spring member 4672 is preferablymanufactured from stainless steel and has a medial portion 4682 which ispartially received in the longitudinal notch portion 4676, an angledproximal portion 4684 which is fixedly received in the angled channelportion 4678, and a transverse distal portion 4686 which is slidablyreceived in the transverse channel 4680. The medial portion 4682 of thespring member 4672 is partially exposed from the distal tip portion 4666and normally biased in a transverse outward direction with respect tothe longitudinal axis (indicated by arrow E), in order to supply bearingforce against the wall of the recess 4628. Alternatively, the distal tipportion of the screw driver may be magnetized in order to hold the screwportion 4602. Similarly, the distal tip portion may include a ballbearing or similar member which is normally biased in a radially outwarddirection to engage the interior wall of the recess 4628 to secure thefastener 4600 to the screwdriver distal tip 4666.

The insertion of the fastener 4600 into the prepared hole 4092 may beachieved by insertion of screwdriver 4660 into conduit 1020 (indicatedby arrow G). This procedure may be visualized by the use of theendoscope 1500 in conjunction with fluoroscopy. The screw portion 4602is threaded into the prepared hole 4092 by the endoscopic screwdriver4660 (indicated by arrow H). The endoscopic screwdriver 4660 issubsequently separated from the screw, by applying a force in theproximal direction, and thereby releasing the distal tip portion 4666from the hexagonal recess 4628 (e.g., causing the transverse distalportion 4686 of the spring member 4672 to slide within the transverserecess 4680 against the bias, indicated by arrow F), and removing thescrewdriver 4660 from the expandable conduit 1020. An alternative methodmay use a guide wire, which is fixed in the hole 4092, and a cannulatedscrew which has an internal lumen (as is known in the art) and is guidedover the guide wire into the hole 4092. The screwdriver would becannulated as well to fit over the guide wire.

For a two-level fixation, it may be necessary to prepare several holesand attach several fasteners 4600. Typically, the expandable conduitwill be sized in order to provide simultaneous access to all vertebraein which the surgical procedure is being performed. In some cases,however, additional enlargement or repositioning of the distal portionof the expandable conduit may be required in order to have sufficientaccess to the outer vertebrae, e.g., the L4 and S1 vertebrae. In theexemplary embodiment, the expander apparatus 1200 may be repeatedlyinserted into the expandable conduit 1020 and expanded in order tofurther open or position the skirt portion 1024. In the exemplaryprocedure, additional fasteners are inserted in the L4 and S1 vertebraein a similar fashion as the fastener 4600 inserted in to the L5 vertebraas described above. (When discussed individually or collectively, afastener and/or its individual components will be referred to by thereference number, e.g., fastener 4600, housing 4604, and all fasteners4600. However, when several fasteners and/or their components arediscussed in relation to one another, an alphabetic subscript will beused, e.g., fastener 4600 a is moved towards fastener 4600 b.)

In a further stage of the procedure, the housing portions 4604 of thefasteners 4600 are substantially aligned such that their uprightportions 4630 and 4631 face upward, and the notches 4632 aresubstantially aligned to receive the fixation element or elongatedmember 4650 therein. The frictional mounting of the housing 4604 to thescrew member 4602, described above, allows the housing 4604 to betemporarily positioned until a subsequent tightening step, describedbelow. Positioning of the housing portions 4604 may be performed by theuse of an elongated surgical instrument capable of contacting and movingthe housing portion to the desired orientation. An exemplary instrumentfor positioning the housings 4604 is a grasper apparatus 4700,illustrated in FIG. 89. The grasper apparatus 4700 includes a proximalhandle portion 4702, an elongated body portion 4704, and distal noseportion 4706. The distal nose portion 4706 includes a pair of graspingjaws 4708 a and 4708 b, which are pivotable about pin 4710 by actuationof the proximal handle portion 4702. The grasping jaws 4708 a and 4708 bare illustrated in the closed position in FIG. 89. As is known in theart, pivoting the movable handle 4714 towards stationary handle 4712causes longitudinal movement of actuator 4716, which in turn pivots thejaw 4708 b towards an open position (illustrated in dashed line). Thebiasing members 4718 and 4720 are provided to return the handles 4712and 4714 to the open position and bias the jaws 4708 a and 4708 b to theclosed position.

A subsequent stage in the process is the insertion of the fixationelement or elongated member 4650 into the expandable conduit 1020. Theelongated member is manufactured from a biocompatible material and mustbe sufficiently strong to maintain the positioning of the vertebrae, orother body structures. In the exemplary embodiment, the elongatedmembers 4650 are manufactured from Titanium 6/4 or titanium alloy.Alternatively, the elongated member may be manufactured from stainlesssteel or other suitable material. The radii and length of the elongatedmembers 4650 are selected by the physician to provide the best fit forthe positioning of the screw heads. Such selection may be performed byplacing the elongated member 4650 on the skin of the patient overlyingthe location of the fasteners and viewed fluoroscopically. For example,a 70 mm preformed rod having a 3.5 bend radius may be selected for thespinal fixation.

The elongated member 4650 is subsequently fixed to each of the fasteners4600, and more particularly, to the housings 4604 of each fastener. Thegrasper apparatus 4700, described above, is also particularly useful forinserting the elongated member 4650 into the expandable conduit 1020 andpositioning it with respect to each housing 4604. As illustrated in FIG.89, the jaws 4708 a and 4708 b of the grasper apparatus 4700 each has acurved contact portion 4722 a and 4722 b for contacting and holding theouter surface of the elongated member 4650.

As illustrated in FIG. 90, the grasper apparatus 4700 may be used toinsert the elongated member 4650 into the operative space 1090 definedat least partially by the skirt portion 1024 of the expandable conduit1020. The cut-out portions 1056 and 1058 provided in the skirt portion1024 assist in the process of installing the elongated member 4650 withrespect to the housings 4604. The cut-out portions 1056 and 1058 allowan end portion 4652 of the elongated member 4650 to extend beyond theoperative space without raising or repositioning the skirt portion 1024.The elongated member 4650 is positioned within the recesses in eachhousing 4604 defined by grooves 4632 disposed between upright members4630 and 4631. The elongated member 4650 is positioned in an orientationsubstantially transverse to the longitudinal axis of each housing 4604.

Further positioning of the elongated member 4650 may be performed byguide apparatus 4800, illustrated in FIG. 91. Guide apparatus 4800 isuseful in cooperation with an endoscopic screwdriver, such as endoscopicscrewdriver 4660 (illustrated in FIG. 87), in order to position theelongated member 4650, and to introduce and tighten the cap screw 4610,described above and illustrated in FIG. 86. Tightening of the cap screw4610 with respect to the housing 4604 fixes the orientation of thehousing 4604 with respect to the screw portion 4602 and fixes theposition of the elongated member 4650 with respect to the housing 4604.

In the exemplary embodiment, the guide apparatus 4800 has a proximalhandle portion 4802, an elongated body portion 4804, and a distal toolportion 4806. The elongated body portion 4804 defines a central bore4808 (illustrated in dashed line) along its longitudinal axis 4810. Thecentral bore 4808 is sized and configured to receive the endoscopicscrewdriver 4660 and cap screw 4610 therethrough. In the exemplaryembodiment, the diameter of the central bore 4808 of the elongated bodyportion 4804 is about 0.384-0.388 inches in diameter, and the externaldiameter of the endoscopic screwdriver 4660 (FIG. 87) is about 0.25inches. The proximal handle portion 4802 extends transverse to thelongitudinal axis 4810, which allows the physician to adjust the guideapparatus 4800 without interfering with the operation of the screwdriver4660.

The distal portion 4806 of the apparatus includes several semicircularcut out portions 4814 which assist in positioning the elongated member4650. As illustrated in FIG. 92, the cut out portions 4814 are sized andconfigured to engage the surface of elongated member 4650 and move theelongated member 4650 from an initial location (illustrated in dashedline) to a desired location.

As illustrated in FIG. 93, the guide apparatus 4800 is used incooperation with the endoscopic screwdriver 4660 to attach the cap screw4610. The distal end of the body portion 4804 includes a pair ofelongated openings 4816, which permit the physician to endoscopicallyview the cap screw 4610 retained at the distal tip 4666 of theendoscopic screw driver 4660.

The guide apparatus 4800 and the endoscopic screwdriver 4660 maycooperate as follows: The guide apparatus 4800 is configured to bepositioned in a surrounding configuration with the screwdriver 4600. Inthe exemplary embodiment, the body portion 4804 is configured forcoaxial placement about the screwdriver 4660 in order to distribute thecontact force of the guide apparatus 4800 on the elongated member 4650.The distal portion 4806 of the guide apparatus 4800 may bear down on theelongated member 4650 to seat the elongated member 4650 in the notches4632 in the housing 4604. The “distributed” force of the guide apparatus4800 may contact the elongated member 4650 on at least one or morelocations. In addition, the diameter of central bore 4808 is selected tobe marginally larger than the exterior diameter of cap screw 4610, suchthat the cap screw 4610 may freely slide down the central bore 4808,while maintaining the orientation shown in FIG. 93. This configurationallows the physician to have effective control of the placement of thecap screw 4610 into the housing 4604. The cap screw 4610 is releasablyattached to the endoscopic screwdriver 4660 by means of spring member4672 engaged to the interior wall of hexagonal recess 4611 as it isinserted within the bore 4808 of the body portion 4804 of guideapparatus 4800. The cap screw 4610 is attached to the housing 4604 byengaging the threads 4615 of the cap screw 4610 with the threads 4634 ofthe housing.

As illustrated in FIG. 94, tightening of the cap screw 4610 fixes theassembly of the housing 4604 with respect to the elongated member 4650.In particular, the distal surface of the cap screw 4610 provides adistal force against the elongated member 4650, which in turn drives thespacer member 4606 against the joint portion 4614 of the screw portion4602, which is consequently fixed with respect to the housing 4604.

If locations of the vertebrae are considered acceptable by thephysician, then the fixation procedure is substantially complete oncethe cap screws 4610 have been attached to the respective housings 4604,and tightened to provide a fixed structure as between the elongatedmember 4650 and the various fasteners 4600. However, if compression ordistraction of the vertebrae with respect to one another is requiredadditional apparatus would be used to shift the vertebrae prior to finaltightening of all the cap screws 4610.

In the exemplary embodiment, this step is performed with a surgicalinstrument, such as compressor-distracter instrument 4900, illustratedin FIG. 95, which is useful to relatively position bone structures inthe cephalad-caudal direction and to fix their position with respect toone another. Thus, the compressor-distracter instrument 4900 has thecapability to engage two fasteners 4600 and to space them apart whilesimultaneously tightening one of the fasteners to fix the spacingbetween the two vertebrae, or other bone structures. Moreover, thecompressor-distracter instrument 4900 may also be used to move twofasteners 4600, and the vertebrae attached thereto into closerapproximation and fix the spacing there between.

The distal tool portion 4902 of the compressor-distracter instrument4900 is illustrated in FIG. 95. (Further details of thecompressor-distracter apparatus is described in co-pending U.S.application Ser. No. 10/178,875, filed Jun. 24, 2002, entitled “SurgicalInstrument for Moving Vertebrae,” which is hereby incorporated byreference in its entirety herein.) The distal tool portion 4902 includesa driver portion 4904 and a spacing member 4906. The driver portion 4904has a distal end portion 4908 with a plurality of wrenching flatsconfigured to engage the recess 4611 in the proximal face of the capscrew 4610, and to apply torque to the cap screw. The driver portion4904 is rotatable about the longitudinal axis (indicated by arrow M) torotate the cap screw 4610 relative to the fastener 4600. Accordingly,the driver portion 4904 can be rotated to loosen the cap screw 4610 onthe fastener 4600 and permit movement of the elongated member 4650connected with one of the vertebrae relative to the fastener 4600connected with another of the vertebrae. The cap screw 4610 can also berotated in order to tighten the cap screw 4610 and clamp the elongatedmember 4650 to the fastener 4600.

The distal tool portion 4902 may also include a spacing member, such asspacing member 4906, which engages an adjacent fastener 4600 b whiledriver member 4904 is engaged with housing 4600 a to move the fastener4600 b with respect to fastener 4600 a. In the exemplary embodiment,spacing member 4906 is a jaw portion which is pivotably mounted to movebetween a first position adjacent the driver portion and a secondposition spaced from the driver portion, as shown in FIG. 95. The distaltip 4910 of the spacing member 4906 is movable relative to the driverportion 4904 in a direction extending transverse to the longitudinalaxis.

As illustrated in FIG. 95, the spacer member 4906 can be opened withrespect to the driver portion 4904 to space the vertebrae further apart(as indicated by arrow N). The distal portion 4910 of the spacer member4906 engages the housing 4604 b of fastener 4600 b and moves fastener4600 b further apart from fastener 4600 a to distract the vertebrae.Where the vertebrae are to be moved closer together, e.g. compressed,the spacer member 4906 is closed with respect to the driver portion 4904(arrow P), as illustrated in FIG. 96. The distal portion 4610 of spacermember 4606 engages housing 4604 b of fastener 4600 b and moves fastener4600 b towards fastener 4600 a. When the spacing of the vertebrae isacceptable to the physician, the cap screw 4610 a is tightened by thedriver member 4904, thereby fixing the relationship of the housing 4604a with respect to elongated member 4650, and thereby fixing the positionof the vertebrae, or other bone structures, with respect to one another.

Once the elongated member or fixing element 4650 is fixed with respectto the fasteners 4600, the procedure is substantially complete. Thesurgical instrumentation, such as the endoscope 1500 is withdrawn fromthe surgical site. The expandable conduit 1020 is also withdrawn fromthe site. The muscle and fascia typically close as the expandableconduit 1020 is withdrawn through the dilated tissues in the reducedprofile configuration. The fascia and skin incisions are closed in thetypical manner, with sutures, etc. The procedure described above may berepeated for the other lateral side of the same vertebrae, if indicated.

Accordingly, the method of fixing three vertebrae V of a patienttogether at the surgical site includes inserting a first cannula 1020into the body of the patient. The skirt portion 1024 of the cannula 1020is expanded using the expander apparatus 1200. A first fusion device2010 or 2110 is moved through the cannula 1020 and inserted between thefirst and second vertebrae V. A first fastener 4600 is moved through thecannula 1020 and secured to the first vertebra V. A second fastener 4600is moved through the cannula 1020 and secured to a second vertebra V. Asecond fusion device 2010 or 2110 is moved through the cannula 1020 andinserted between the second and third vertebrae V. A third fastener 4600is moved through the cannula 1020 and secured to the third vertebra V. Afirst fixation element 4650 is moved through the cannula 1020. The firstfixation element 4650 is fixed to the first, second, and third fasteners4600.

A second cannula 1020 is inserted into the body of the patient laterallyfrom where the first cannula was inserted. The skirt portion 1024 of thesecond cannula 1020 is expanded using the expander apparatus 1200. Athird fusion device 2010 or 2110 is moved through the cannula 1020 andinserted between the first and second vertebrae V. A fourth fastener4600 is moved through the second cannula 1020 and secured to the firstvertebra V. A fifth fastener 4600 is moved through the cannula 1020 andsecured to the second vertebra V. A fourth fusion device 2010 or 2110 ismoved through the second cannula 1020 and inserted between the secondand third vertebrae V. A sixth fastener 4600 is moved through the secondcannula 1020 and secured to the third vertebra V. A second fixationelement 4650 is moved through the second cannula 1020. The secondfixation element 4650 is fixed to the fourth, fifth, and sixthfasteners.

Although the method of securing the three vertebrae together isdescribed as including the insertion of fusion devices between thesecond and third vertebrae, it is contemplated that fusion devices mayonly be inserted between the first and second vertebrae. Furthermore, itis contemplated that the skirt portion 1024 of the cannula 1020 couldinclude a stop that retains the skirt portion in an expandedconfiguration as shown in U.S. patent application Ser. No. 09/855,358,now U.S. Pat. No. 6,524,320, which is hereby incorporated by referencein its entirety herein.

FIGS. 97-103 illustrate various embodiments of another access devicedesignated by reference number 5000. The term “access device” is used inits ordinary sense to mean a device that can provide access and is abroad term and it includes structures having an elongated dimension anddefining a passage, e.g., a cannula or a conduit. With reference toFIGS. 97 and 98, the access device 5000 is configured to be insertedthrough the skin of the patient to provide access during a surgicalprocedure to a surgical location within a patient, e.g., a spinallocation. The term “surgical location” is used in its ordinary sense(i.e. a location where a surgical procedure is performed) and is a broadterm and it includes locations subject to or affected by a surgery. Theterm “spinal location” is used in its ordinary sense (i.e. a location ator near a spine) and is a broad term and it includes locations adjacentto or associated with a spine that may be sites for surgical spinalprocedures. The access device 5000 also can retract tissue to providegreater access to the surgical location.

The access device 5000 has an elongate body 5002 that has a proximal end5004 and a distal end 5006. With reference to FIGS. 97 and 98, theelongate body 5002 has a length 5008 between the proximal end 5004 andthe distal end 5006. The length 5008 is selected such that when theaccess device 5000 is applied to a patient during a surgical procedure,the distal end 5006 can be positioned inside the patient adjacent thespinal location. When so applied, the proximal end 5004 is preferablyoutside the patient at a suitable height, as discussed more fully below.

In one embodiment, the elongate body 5002 comprises a proximal portion5010 and a distal portion 5012. The proximal portion 5010 has an oblongor generally oval shaped cross section in one embodiment. The term“oblong” is used in its ordinary sense (i.e., having an elongated form)and is a broad term and it includes a structure having a dimension,especially one of two perpendicular dimensions, such as, for example,width or length, that is greater than another and includes shapes suchas rectangles, ovals, elipses, triangle, diamonds, trapezoids,parabolas, and other elongated shapes having straight or curved sides.The term “oval” is used in its ordinary sense (i.e., egg like oreliptical) and is a broad term and includes oblong shapes having curvedportions.

The distal portion 5012 is expandable in one embodiment. At least onepassage 5014 extends through the elongate body 5002 between the proximalend 5004 and the distal end 5006, e.g., through the proximal and distalportions 5010, 5012. The passage 5014 preferably is defined by a smoothmetal inner surface 5016 that extends substantially entirely around theperimeter of the passage 5014 between the proximal and distal ends 5004,5006 in one embodiment. The inner surfaces 5016 can take other forms,e.g., employing other materials, different smoothness, and/or varyingdegrees of smoothness.

In one embodiment, the elongate body 5002 is expandable from a firstconfiguration, shown in FIG. 102, to a second configuration, shown inFIG. 101. In one embodiment, the elongate body 5002 is movable from thefirst configuration to the second configuration when inserted within thepatient, as discussed above. In the first configuration, the accessdevice 5000 is configured, e.g., sized, for insertion into the patient.As discussed more fully below, in one embodiment, the firstconfiguration of the access device 5000 provides that the passage 5014has a relatively small transverse cross-sectional area at the distal end5006, e.g., a cross-sectional area about equal to the cross-sectionalarea of the proximal end 5004, or less.

In the second configuration, the cross-sectional area of the passage5014 at the distal end 5006 is greater than the cross-sectional area ofthe passage 5014 at the proximal end 5004 in one embodiment. The secondconfiguration is particularly well suited for performing surgicalprocedures in the vicinity of a spinal location. Other configurationsand arrangements of the access device 5000 are discussed herein below.

As shown in FIGS. 97 and 98, in one embodiment, the proximal portion5010 and the distal portion 5012 are discrete, i.e., separate members.In other embodiments, the proximal and distal portions 5010, 5012 are aunitary member. In the illustrated embodiment, the proximal portion 5010comprises an oblong, generally oval shaped cross section over theelongated portion. It will be apparent to those of skill in the art thatthe cross section can be of any suitable oblong shape. The proximalportion 5010 can be any desired size. The proximal portion 5010 can havea cross-sectional area that varies from one end of the proximal portion5010 to another end. For example, the cross-sectional area of theproximal portion 5010 can increase or decrease along the length of theproximal portion 5010. Preferably, the proximal portion 5010 is sized toprovide sufficient space for inserting multiple surgical instrumentsthrough the elongate body 5002 to the surgical location.

As shown in FIG. 97, the generally oval shaped cross section of theproximal portion 5010 in one embodiment has a first dimension 5026 ofabout 24 mm and a second dimension 5028 of about 35 mm. The first andsecond dimensions 5026, 5028 could range from at least about 10 mm up toabout 70 mm or more. The proximal portion 5010 in one embodiment has athird dimension 5030 of about 50 mm, but the third dimension 5030 couldrange from about 10 mm up to about 180 mm or more. In one embodiment,the proximal portion 5010 extends distally at least partially into thedistal portion 5012 of the device 5000, as shown in FIG. 100. In FIG.97, the proximal portion 5010 extends a distance 5032 of about 10 mminto the distal portion 5012. The proximal portion 5010 can extend adistance 5032 of between about 5 mm and about 20 mm into the distalportion 5012 in some embodiments. The exposed portion of the proximalportion 5010 (i.e., the portion thereof that extends proximally of thedistal portion 5012) can be of any suitable height. Additionally, thedistance 5032 that the proximal portion 5010 extends into the distalportion 5012 can be increased or decreased, as desired.

As shown in FIGS. 97 and 98, the proximal portion 5010 is coupled withthe distal portion 5012, e.g., with one or more couplers 5050.Preferably the proximal and distal portions 5010, 5012 are coupled on afirst lateral side 5062 and on a second lateral side 5064 with thecouplers 5050. When applied to a patient in a posterolateral procedure,either of the first or second lateral sides 5062, 5064 can be a medialside of the access device 5000, i.e., can be the side nearest to thepatient's spine. Couplers 5050 can be any suitable coupling devices,such as, for example, rivet attachments. In one embodiment, the couplers5050 are located on a central transverse plane of the access device5000.

The couplers 5050 preferably allow for rotation and pivotal movement ofthe proximal portion 5010 relative the distal portion 5012. A portion ofthe range of rotation and pivotal movement of the proximal portion 5010relative the distal portion 5012 can be seen by comparing the positionof the proximal portion 5010 in FIG. 97 to the position thereof in FIG.99. In FIG. 99, the proximal portion 5010 is seen at an angle α of about20 degrees with respect to a transverse plane extending verticallythrough the couplers. One skilled in the art will appreciate thatrotating or pivoting the proximal portion 5010 to the angle α permitsenhanced visualization of and access to a different portion of thespinal location accessible through the access device 5000 than would bevisualized and accessible at a different angle. Depending on the size ofthe distal portion 5012, the angle α can be greater than, or less than,20 degrees. Preferably, the angle α is between about 10 and about 40degrees.

The pivotable proximal portion 5010 allows for better access to thesurgical location and increased control of surgical instruments.Additionally, the generally oval shape of the proximal portion 5010 hasincreased the cross-sectional area available for a variety ofprocedures, some of which may require or benefit from more proximal endexposure. Embodiments having a generally oval shape can also be employedadvantageously in procedures such as the lateral or postero-lateralplacement of artificial disks, as well as other developing procedures.

As discussed above, the distal portion 5012 is expandable in oneembodiment. As shown in FIG. 100, the degree of expansion of the distalportion 5012 is determined by an amount of overlap between a first skirtmember 5034 and a second skirt member 5036 in one embodiment. Inparticular, the first skirt member 5034 has a first overlapping portion5090 on the first lateral side 5062 and the second skirt member 5036 hasa second overlapping portion 5092 on the first lateral side 5062. Thefirst skirt member 5034 has a third overlapping portion 5094 on thesecond lateral side 5064 and the second skirt member 5036 has a fourthoverlapping portion 5096 on the second lateral side 5064. The first andsecond overlapping portions 5090, 5092 overlap to define a first overlaparea 5098. The third and fourth overlapping portions 5094, 5096 overlapto define a second overlap area 5100. The extents of the first andsecond overlap areas 5098, 5100 preferably are reduced when the distalportion 5012 is in the second configuration. The extents of the firstand second overlap areas 5098, 5100 preferably are increased when thedistal portion 5012 is in the first configuration.

The distal portion 5012 preferably is manufactured from a rigidmaterial, such as stainless steel. The distal portion 5012 of the accessdevice 5000 can be manufactured from a sheet of stainless steel having athickness of between about 0.003-0.010 inches. In some embodiments, thethickness is about 0.007 inches. Other materials, such as Nitinol,plastics, or other suitable materials can also be used.

In some embodiments, the distal portion 5012 can be manufactured so thatit normally assumes an expanded configuration. Additionally, the distalportion 5012 can assume an intermediate configuration and correspondingcross-sectional area, which has greater dimensions than the firstconfiguration, and smaller dimensions than the second configuration.Alternatively, an expander apparatus, similar to those previouslydiscussed herein, can be used to expand the distal portion 5012 asuitable amount.

The skirt members 5034, 5036 preferably are slidably coupled together.In one embodiment, the first and second skirt members 5034, 5036 areslidably coupled to each other with at least one guide member disposedin at least one slot defined in each of the skirt members 5034, 5036. Inparticular, a first slot 5102 is formed in the first overlapping portion5090 of the first skirt member 5034 and a second slot 5104 is formed inthe second overlapping portion 5092 of the second skirt member 5036 onthe first lateral side 5062 of the access device 5000. A guide member5106 extends through the first and second slots 5102, 5104 and istranslatable therein. Similarly, a third slot 5108 is formed in thethird overlapping portion 5094 of the first skirt member 5034 and afourth slot 5110 is formed in the fourth overlapping portion 5096 of thesecond skirt member 5036 on the second lateral side 5064 of the accessdevice 5000. A guide member 5112 extends through the third and fourthslots 5108, 5110 and is translatable therein.

Any suitable mechanism for slidably coupling the skirt members 5034,5036 can be used. In the illustrated embodiment, two floating rivets areused as guide members 5106, 5112. In another embodiment, one or more ofthe slots 5102, 5104, 5108, 5110 can include a locking or ratchetingmechanism (not shown). Locking mechanism is used in its ordinary sense(i.e. a mechanism to maintain relative positions of members) and is abroad term and it includes structures' having detent arrangements,notches, and grooves. Some additional examples of locking mechanisms aredisclosed in U.S. patent application Ser. No. 10/361,887, filed Feb. 10,2003, entitled “Structure for Receiving Surgical Instruments,” publishedas application publication No. US2003/0153927 on Aug. 14, 2003, which ishereby incorporated by reference herein in its entirety.

With reference to FIGS. 97-102, as discussed above, the skirt members5034, 5036 preferably pivot about couplers 5050 joining the proximalportion 5010 with the distal portion 5012. The distal portion 5012preferably pivots on an axis perpendicular to the longitudinal axis ofthe access device 5000. This arrangement is particularly useful forproviding surgical access to anatomical features generally located andoriented along the Cephalad-Caudal direction.

As discussed above, the access device 5000 can be expanded from thefirst configuration to the second configuration by way of the movementof the first skirt member 5034 relative to the second skirt member 5036.In the illustrated embodiment, the distal portion 5012 is generally ovalshaped both in the first configuration, when the device 5000 isgenerally contracted, and in the second configuration, when the device5000 is generally expanded. However, the distal portion 5012 may beconfigured to transition from a generally circular cross-section distalend (or other convenient shape) in the first configuration to agenerally oval cross-section distal end in the second configuration.

As best seen in FIG. 102, the distal portion 5012 preferably has a firstdimension 5052 in the first configuration of approximately 24 mm and asecond dimension 5054 of approximately 35 mm. As best seen in FIG. 101,the distal portion 5012 preferably has a first dimension 5056 ofapproximately 45 mm and a second dimension 5058 of approximately 70 mmin the second configuration. Accordingly, in one embodiment in theexpanded configuration the distal portion 5012 opens distally toapproximately 45 mm by 70 mm. The distal portion 5012 can be arranged toopen more or less, as needed or desired. For example, the distal portion5012 can take on an oval shape wherein the second dimension 5058 islonger than 70 mm, e.g., about 85 mm or more. Alternatively, the distalportion 5012 can have a shape wherein the second dimension 5058 isshorter than 70 mm, e.g., about 45 mm or less. Similarly, in someembodiments the first dimension 5052 can be longer or shorter than 45mm, e.g., about 35 mm or about 55 mm. As shown in FIG. 97, the distalportion 5012 has a height 5060 that is approximately 45 mm. However, oneskilled in the art should recognize that the height 5060 of the distalportion 5012 can be any suitable height. The height 5060 preferably iswithin the range of about 20 mm to about 150 mm. Access devices havingrelatively shorter skirt heights 5060 may be advantageous for use withpatients having relatively less muscle tissue near the surgical locationand generally require smaller incisions. Access devices havingrelatively longer skirt height 5060 may be advantageous for use withpatients having relatively more muscle tissue near the surgicalloaction, and may provide greater access.

The distal portion 5012 preferably is sufficiently rigid that it iscapable of displacing surrounding tissue as the distal portion 5012expands. Depending upon the resistance exerted by the surroundingtissue, the distal portion 5012 is sufficiently rigid to provide someresistance against the tissue to remain in the second, expandedconfiguration. Moreover, the second configuration is at least partiallysupported by the body tissue of the patient. The displaced tissue tendsto provide pressure distally on the distal portion 5012 to at leastpartially support the access device 5000 in the second configuration.The rigidity of the distal portion 5012 and the greater expansion at thedistal end 5006 creates a stable configuration that is at leasttemporarily stationary in the patient, which at least temporarily freesthe physician from the need to actively support the elongate body 5002.

Another advantageous aspect of the access device 5000 is illustratedwith reference to FIGS. 101 and 102. In particular, the elongate body5002 has a first location 5068 and a second location 5070. The firstlocation 5068 is distal of the second location 5070. The elongate body5002 is capable of having a configuration when inserted within thepatient wherein the cross-sectional area of the passage 5014 at thefirst location 5068 is greater than the cross-sectional area of thepassage 5014 at the second location 5070. The passage 5014 is capable ofhaving an oblong shaped cross section between the second location 5070and the proximal end 5004.

In some embodiments the passage 5014 preferably is capable of having agenerally elliptical cross section between the second location 5070 andthe proximal end 5004. Additionally, the passage 5014 preferably iscapable of having a non-circular cross section between the secondlocation 5070 and the proximal end 5004. Additionally, in someembodiments, the cross section of the passage 5014 can be symmetricalabout a first axis 5072 and a second axis 5074, the first axis 5072being generally normal to the second axis 5074.

As shown in FIG. 101, the configuration of the elongate body 5002between the first location 5068 and the second location 5070 isgenerally conical, when the elongate body 5002 is expanded within thepatient. The term “conical” is used in its ordinary sense (i.e. asurface formed by line segments joining every point of the boundary of aclosed base to a common vertex) and is a broad term and it includesstructures having a generally oblong, or oval, cross section, as well asstructures having a surface that extends only partially toward a vertex.In some embodiments, the first location 5068 can be near a distal end5006 of the elongate body 5002, and the second location 5070 can be neara proximal end 5004 of the elongate body 5002.

In the illustrated embodiment, the elongate body 5002 has an oblongshaped cross section near its proximal end 5004 at least when theelongate body 5002 is in the second configuration. In some embodiments,the elongate body 5002 has an oblong shaped cross section alongsubstantially the entire length between the proximal end 5004 and thesecond location 5070.

Additionally, in some embodiments the passage 5014 can have a generallyoval shaped cross section between the second location 5070 and theproximal end 5004. The elongate body preferably has a generally ovalshaped cross section at its proximal end 5004 at least when the elongatebody 5002 is in the second configuration. The elongate body 5002 canhave a generally oval shaped cross section along substantially theentire length between the proximal end 5004 and the second location5070. The passage 5014 can also have a cross section between the secondlocation 5070 and the proximal end 5004 where the cross section isdefined by first and second generally parallel opposing side portions5076, 5078 and first and second generally arcuate opposing side portions5080, 5082.

In some embodiments, it is useful to provide a structure to maintain theaccess device 5000 in an un-expanded state until expansion of the deviceis desired. As shown in FIG. 103, in one embodiment an outer sleeve5084, e.g., a plastic sleeve, is provided which surrounds the accessdevice 5000 and maintains the distal portion 5012 in the firstconfiguration. The outer sleeve 5084 can be produced to function aspreviously described herein with reference to other embodiments. Forexample, the outer sleeve 5084 can have a braided polyester suture 5086embedded within it, aligned substantially along the longitudinal axisthereof, such that when the suture 5086 is withdrawn, the sleeve 5084 istorn, which allows the access device 5000 to expand, either resilientlyor mechanically, from the first configuration to the secondconfiguration.

In a method for accessing a surgical location within a patient an accessdevice, such as the access device 5000, is provided. As stated above,the elongate body 5002 is capable of having a first configuration sizedfor insertion into the patient. The elongate body 5002 is capable ofhaving a second configuration when expanded within the patient. In thesecond configuration, the cross-sectional area of the passage 5014 at afirst location 5068 is greater than the cross-sectional area of thepassage 5014 at a second location 5070. The first location 5068 isdistal to the second location 5070. The passage 5014 is capable ofhaving an oblong shaped cross section between the second location 5070and the proximal end 5004. The method comprises inserting the accessdevice 5000, in the first configuration, into the patient to thesurgical location and expanding the device to the second configuration.

The access device 5000 is inserted to a spinal location in some methods.As shown in FIG. 103, an oblong shaped dilator 5088 preferably isinserted into the patient prior to insertion of the access device 5000.In some applications, the access device 5000 may be inserted laterallyto the spinal location. In other applications, the device 5000 isinserted posterolaterally to the spinal location. In some applications,the device 5000 is inserted anteriorly to the spinal location. Thedevice 5000 preferably can be expanded in a cephalad-caudal direction ata spinal location.

With reference to FIG. 103, an early stage in one method involvesdetermining an access point in the skin of the patient to insert theaccess device 5000. An incision is made at the determined location. Insome cases, the incision is approximately 1″ to 2″ long. A guide wire(not shown) is introduced under fluoroscopic guidance through theincision and past the skin, fascia, and muscle to the approximatesurgical site. A series of oblong, or generally oval shaped, dilators isused to sequentially expand the incision to the desired widths, about 24mm by 35 mm for the illustrated embodiment, without damaging thestructure of surrounding tissue and muscles. A first oblong dilator isplaced over the guide wire, which expands the opening. The guide wire isthen subsequently removed. A second oblong dilator that is slightlylarger than the first dilator is placed over the first dilator, whichexpands the opening further. Once the second dilator is in place, thefirst dilator is subsequently removed. This process of (1) introducing anext-larger-sized dilator coaxially over the previous dilator and (2)subsequently removing the previous dilator when the next-larger-sizeddilator is in place continues until an opening of the desired size iscreated in the skin, muscle, and subcutaneous tissue. For theillustrated embodiment, these dimensions are about 24 mm by about 35 mm.(Other dimensions for the openings that are useful with some embodimentsin connection with spinal surgery range from about 20 mm to about 50 mm,and still other dimensions are contemplated.) In some other embodiments,a series of dilators having circular cross sections are used topartially dilate the opening. Then, a final dilator having a circularinner diameter and an oblong or generally oval shaped outer perimetercan be used to further dilate the opening.

As illustrated in FIG. 103, following placement of the largest oblong,or generally oval shaped dilator 5088, the access device 5000, in thefirst configuration, is introduced and positioned in a surroundingrelationship over the dilator 5088. The dilator 5088 is subsequentlyremoved from the patient, and the access device 5000 is allowed toremain in position.

Once the access device 5000 is positioned in the patient, it can beenlarged to provide a passage 5014 for the insertion of various surgicalinstrumentation and an enlarged space for performing the proceduresdescribed herein. As described above, the elongate body 5002 canaccommodate the enlargement in several ways. In the illustratedembodiment, the distal portion 5012 of the device 5000 can be enlarged,and the proximal portion 5010 can maintain an oblong shape. The relativelengths of the proximal portion 5010 and the distal portion 5012 can beadjusted to vary the overall expansion of the access device 5000.Alternatively, in some embodiments expansion can extend along the entirelength of the elongate body 5002.

In the illustrated embodiment, the access device 5000 can be expanded byremoving the suture 5086 and tearing the sleeve 5084 surrounding theaccess device 5000, and subsequently expanding the distal portion 5012mechanically, or allowing the distal portion 5012 to resiliently expandtowards the expanded configuration, to create an enlarged surgicalspace. In some embodiments, the enlarged surgical space extends from theL4 to the S1 vertebrae.

The access device 5000 can be enlarged at its distal portion 5012 usingan expander apparatus to create a surgical access space. An expanderapparatus useful for enlarging the elongate body 5002 has a reducedprofile configuration and an enlarged configuration. Additionally, theexpander apparatus can have an oblong, or generally oval shape. Theexpander apparatus is inserted into the elongate body 5002 in thereduced profile configuration, and subsequently expanded to the enlargedconfiguration. The expansion of the expander apparatus also causes theelongate body 5002 to be expanded to the enlarged configuration. In someembodiments, the expander apparatus can increase the cross-sectionalarea of the elongate body 5002 along substantially its entire length. Inother embodiments, the expander apparatus expands only a distal portion5012 of the elongate body 5002, allowing a proximal portion 5010 tomaintain a constant oblong, or generally oval shape. Other expanderapparatus are disclosed in U.S. patent application Ser. No. 10/665,754,entitled “Surgical Tool for Use in Expanding a Cannula”, filed on Sep.19, 2003.

In addition to expanding the elongate member 5002, the expanderapparatus can also be used to position the distal portion 5012 of theelongate member 5002 at the desired location for the surgical procedurein a manner similar to that described previously with reference toanother embodiment.

Once the distal portion 5012 has expanded, the rigidity and resilientcharacteristics of the distal portion 5012 allow the elongate body 5002to resist closing to the first configuration and to at least temporarilyresist being expelled from the incision. These characteristics create astable configuration for the elongate body 5002 to remain in position inthe body, supported by the surrounding tissue.

The access device 5000, like the other access devices described herein,has a wide variety of applications wherein the passage 5014 providesaccess to one or more surgical instruments for performing a surgicalprocedure. In one application, the passage 5014 provides access toperform a two level posterolateral fixation of the spine involving theL4, L5 and S1 vertebrae. The access devices 5000 can be used to delivera wide variety of fixation elements, including rigid, semi-rigid, ordynamic fixation elements. The access devices are not limited to theposterolateral approach nor to the L4, L5 and S1 vertebrae. The accessdevices may be applied in other anatomical approaches and with othervertebrae within the cervical, thoracic and lumbar spine. The accessdevices can be applied in procedures involving one or more vertebrallevels and in anterior and lateral procedures. Further procedures inwhich the access devices described herein can be applied includeprocedures involving orthobiologics, bone morphogenetic proteins, andblood concentrators. The access devices can also be used with proceduresinvolving prosthetics, such as disc nucleus replacement, facet jointreplacement, or total disc replacement. The access devices can also beapplied in procedures involving vertebroplasty, where a crushedvertebrae is brought back to its normal height.

The access devices described herein also can be used in connection withinterbody fusion, and fusion of the facets and transverse processes.Some of the fusion procedures that can be performed via the accessdevices described herein employ allograft struts, bone filling material(e.g., autograft, allograft or synthetic bone filling material), andcages and/or spacers. The cages and the spacers can be made of metal, apolymeric material, a composite material, or any other suitablematerial. The struts, cages, and spacers are used in the interbody spacewhile the bone filling material can be used both interbody andposterolaterally. Any of the foregoing or other fusion procedures can beused in combination with the orthobiologics and can be performed via theaccess devices described herein.

Some examples of uses of the access devices described in otherprocedures and processes, as well as further modifications andassemblies, are disclosed in U.S. Provisional Patent Application No.60/471,431, filed May 16, 2003, entitled “Access Device For MinimallyInvasive Surgery,” and in U.S. patent application Ser. No. 10/658,736,filed Sep. 9, 2003 which are hereby incorporated by reference herein intheir entireties.

FIGS. 104-109 illustrate embodiments having lighting elements. FIGS.104-106 illustrate one embodiment of a lighting element 5120 coupledwith a support arm 5122 compatible with an access device 5124 having aproximal portion with a generally circular cross section. In otherembodiments, support arms can be configured to be coupled with accessdevices having proximal portions with generally oblong or oval crosssections.

The support arm 5122 preferably is coupled with the access device 5124to provide support for the access device 5124 during a procedure. Asshown in FIGS. 104 and 105, the support arm 5122 comprises a pneumaticelement 5126 for maintaining the support arm 5122 in a desired position.Depressing a button 5128 coupled with a valve of the pneumatic element5126 releases pressure and allows the support arm 5122 and access device5124 to be moved relative the patient 5130. Releasing the button 5128 ofthe pneumatic element 5126 increases pressure and maintains the accessdevice 5124 and support arm 5122 in the desired position. The supportarm 5122, as shown, is configured for use with a mechanical arm using asuction, or a vacuum to maintain the access device in a desiredlocation. One of skill in the art will recognize that various othersupport arms and mechanical arms can be used. For example, commerciallyavailable mechanical arms having clamping mechanisms can be used as wellas suction or pressure based arms.

As shown in FIGS. 104-106, the support arm 5122 can comprise an innerring portion 5132 and an outer ring portion 5134 for surrounding theaccess device 5124 at its proximal end. In the illustrated embodiment,the inner and outer ring portions 5132, 5134 are fixed relative eachother. In other embodiments the inner and outer ring portions 5132, 5134can move relative each other. The support arm 5122 preferably comprisesa lighting element support portion 5136. In the illustrated embodiment,the lighting element support portion 5136 extends above upper surfacesof the inner and outer ring portions 5132, 5134. The lighting elementsupport portion 5136 can extend from the inner ring portion 5132, theouter ring portion 5134, or both. The lighting element support portion5136 can have a notch or groove 5138 for receiving and supporting thelighting element 5120. Additionally, the lighting element supportportion 5136 can have one or more prongs extending at least partiallyover the lighting element 5120 to hold it in place.

In the illustrated embodiment, the lighting element 5120 has anelongated proximal portion 5140 and a curved distal portion 5142. Theproximal portion 5140 of the lighting element 5120 preferably is coupledwith a light source (not shown). The curved distal portion of thelighting element 5120 in one embodiment extends only a short distanceinto the access device and is configured to direct light from the lightsource down into the access device 5124. In another embodiment, thelighting element 5120 can be provided such that it does not extend intothe access device. In such an embodiment, the right portions 5132 and5134 only partially surround the proximal end of the access device 5124.Providing a lighting element 5120 for use with the access device 5124preferably allows a user to see down into the access device 5124 to viewa surgical location. Accordingly, use of a lighting element 5120 can, insome cases, enable the user to perform a procedure, in whole or in part,without the use of an endoscope. In one embodiment, the lighting element5120 enables a surgeon to perform the procedure with the use ofmicroscopes or loupes.

FIGS. 107-109 illustrate other embodiments of lighting elements. Asshown in FIG. 107, a lighting element 5160 comprises a support member5162, an access device insert 5164, and fiber optic elements 5166. Thesupport member 5162 has a proximal end 5168, a central portion 5170, anda distal end 5172. The proximal end 5168 preferably has a couplingportion 5174 for coupling the support member 5162 to a support arm orother support system (not shown). The central portion 5170 preferably iscoupled with the fiber optic elements 5166 to provide support there to.The distal end 5172 preferably is coupled with the access device insert5164.

In the illustrated embodiment, the access device insert 5164 isconfigured to be inserted in an access device having a proximal portionwith a generally circular cross section. The access device insert 5164is coupled with the fiber optic elements 5166. The fiber optic elements5166 extend down into the access device insert 5164 so that the ends ofthe fiber optic elements 5166 can direct light down inside an accessdevice along side portions there of.

FIGS. 108 and 109 illustrate other embodiments of lighting elementssimilar to the embodiment described with reference to FIG. 107.Components of the lighting elements shown in FIGS. 108 and 109 that weredescribed with reference to FIG. 107 are given the same referencenumerals that were used in FIG. 107, except that a ′ is added in FIG.108 and a ″ is added in FIG. 109. As shown in FIGS. 108 and 109, accessdevice inserts 5164′, 5164″ are configured to be inserted into accessdevices having proximal portions with generally oblong, or oval, crosssections. As shown in FIG. 108, the access device insert 5164′ has agenerally oblong or oval shaped cross section. The access device insert5164′ is coupled with the fiber optic elements 5166′ along a longer sidesurface of the access device insert 5164′. As shown in FIG. 109, theaccess device insert 5164″ has a generally oblong or oval shaped crosssection. The access device insert 5164″ is coupled with the fiber opticelements 5166″ along a shorter side surface of the access device insert5164″. Use of an illumination element with an expandable access devicehaving an oblong shaped proximal section, in some cases, allows a doctorto perform procedures that would be difficult to perform using anendoscope. Increased visualization of the surgical location through theaccess device can simplify some procedures. For example, decompressionof the contra-lateral side can be achieved more easily in some caseswithout the use of an endoscope.

The various devices, methods and techniques described above provide anumber of ways to carry out the invention. Of course, it is to beunderstood that not necessarily all objectives or advantages describedmay be achieved in accordance with any particular embodiment describedherein. Also, although the invention has been disclosed in the contextof certain embodiments and examples, it will be understood by thoseskilled in the art that the invention extends beyond the specificallydisclosed embodiments to other alternative embodiments and/or uses andobvious modifications and equivalents thereof. Accordingly, theinvention is not intended to be limited by the specific disclosures ofpreferred embodiments herein.

1. A device for retracting tissue to provide access to a spinal locationwithin a patient, said device comprising: an elongate body having aproximal end and a distal end and defining a length between the proximaland distal ends such that the distal end can be positioned inside thepatient adjacent the spinal location, said elongate body comprising agenerally oval shaped proximal portion and an expandable distal portion;and a passage extending through the elongate body between the proximaland distal ends, said passage being defined by a smooth metal innersurface extending substantially entirely around the perimeter of saidpassage between the proximal and distal ends; wherein said elongate bodyis expandable between a first configuration sized for insertion into thepatient and a second configuration wherein the cross-sectional area ofsaid passage at the distal end is greater than the cross-sectional areaof said passage at the proximal end.
 2. The device of claim 1, whereinsaid distal portion is generally oval shaped in the first configuration.3. The device of claim 1, wherein said proximal portion and said distalportion comprise discrete members.
 4. The device of claim 1, whereinsaid distal portion comprises a first member and a second member.
 5. Thedevice of claim 1, wherein said distal portion comprises a firstoverlapping portion and a second overlapping portion, the first andsecond overlapping portions defining an overlap area, wherein the extentof overlap area is reduced when said distal portion is in the secondconfiguration.
 6. The device of claim 1, wherein said proximal portionis pivotable relative to said distal portion.
 7. The device of claim 1,wherein said distal portion comprises a first dimension of about 24 mmand a second dimension of about 35 mm when said elongate body is in saidfirst configuration.
 8. The device of claim 1, wherein said distalportion comprises a first dimension of about 45 mm and a seconddimension of about 70 mm when said elongate body is in said secondconfiguration.
 9. The device of claim 8, wherein said distal portioncomprises a first dimension of about 24 mm and a second dimension ofabout 35 mm when said elongate body is in said first configuration. 10.The device of claim 1, wherein said proximal portion has a cross sectionhaving a first dimension of about 24 mm and a second dimension of about35 mm.
 11. A device for providing access to a surgical location within apatient, said device comprising: an elongate body having a proximal end,a distal end, and an inner surface, said inner surface defining apassage extending through the elongate body and through which surgicalinstruments can be inserted to the surgical location, said elongate bodycapable of having a configuration when located within the patientwherein the cross-sectional area of said passage at a first location isgreater than the cross-sectional area of said passage at a secondlocation, wherein the first location is distal to the second location,said passage capable of having an oblong shaped cross section betweenthe second location and the proximal end.
 12. The device of claim 11,wherein said passage is capable of having a generally elliptical crosssection between the second location and the proximal end.
 13. The deviceof claim 11, wherein said passage is capable of having a non-circularcross section between the second location and the proximal end.
 14. Thedevice of claim 11, wherein the cross section is symmetrical about afirst axis and a second axis, wherein the first axis is generally normalto the second axis.
 15. The device of claim 11, wherein theconfiguration of the elongate body between the first location and thesecond location is generally conical when the elongate body is locatedwithin the patient.
 16. The device of claim 11, wherein the firstlocation is at a distal end of the elongate body, and the secondlocation is at a proximal end of the elongate body.
 17. The device ofclaim 11, wherein the elongate body is configured to be inserted throughthe skin of the patient and is sized to provide access to a spinallocation.
 18. The device of claim 11, wherein the elongate body ismovable from a first configuration to a second configuration whenlocated within the patient, the second configuration providing thecross-sectional area of said passage at a first location greater thanthe cross-sectional area of said passage at a second location, whereinthe first location is distal to the second location.
 19. The device ofclaim 18, wherein the elongate body is expandable from the firstconfiguration to the second configuration.
 20. The device of claim 18,wherein the elongate body has an oblong shaped cross section at itsproximal end at least when the elongate body is in the secondconfiguration.
 21. The device of claim 20, wherein the elongate body hasan oblong shaped cross section along substantially the entire lengthbetween the proximal end and the second location.
 22. The device ofclaim 21, wherein said elongate body between the proximal end and thesecond location has a cross section having a first dimension of about 24mm and a second dimension of about 35 mm.
 23. A device for providingaccess to a surgical location within a patient, said device comprising:an elongate body having a proximal end, a distal end, and an innersurface, said inner surface defining a passage extending through theelongate body and through which surgical instruments can be inserted tothe surgical location, said elongate body being expandable from a firstconfiguration to a second configuration when located within the patientsuch that in the second configuration the cross-sectional area of saidpassage at a first location is greater than the cross-sectional area ofsaid passage at a second location, wherein the first location is distalto the second location, said passage capable of having a generally ovalshaped cross section between the second location and the proximal end.24. The device of claim 23, wherein the cross section is symmetricalabout a first axis and a second axis, wherein the first axis isgenerally normal to the second axis.
 25. The device of claim 23, whereinthe configuration of the elongate body between the first location andthe second location is generally conical when the elongate body isexpanded within the patient.
 26. The device of claim 23, wherein thefirst location is at a distal end of the elongate body, and the secondlocation is at a proximal end of the elongate body.
 27. The device ofclaim 23, wherein the elongate body is configured to be inserted throughthe skin of the patient and is sized to provide access to a spinallocation.
 28. The device of claim 23, wherein the elongate body has agenerally oval shaped cross section at its proximal end at least whenthe elongate body is in the second configuration.
 29. The device ofclaim 28, wherein the elongate body has a generally oval shaped crosssection along substantially the entire length between the proximal endand the second location.
 30. The device of claim 29, wherein saidelongate body between the proximal end and the second location has across section having a first dimension of about 24 mm and a seconddimension of about 35 mm.
 31. A device for providing access to asurgical location within a patient, said device comprising: an elongatebody having a proximal end, a distal end, and an inner surface, saidinner surface defining a passage extending through the elongate body andthrough which surgical instruments can be inserted to the surgicallocation, said elongate body capable of having a configuration whenlocated within the patient wherein the cross-sectional area of saidpassage at a first location is greater than the cross-sectional area ofsaid passage at a second location, wherein the first location is distalto the second location, said passage capable of having a cross sectionbetween the second location and the proximal end wherein the crosssection is defined by first and second generally parallel opposing sideportions and first and second generally arcuate opposing side portions.32. The device of claim 31, wherein the cross section is symmetricalabout a first axis and a second axis, wherein the first axis isgenerally normal to the second axis.
 33. The device of claim 31, whereinsaid elongate body between the proximal end and the second location hasa cross section having a first dimension of about 24 mm and a seconddimension of about 35 mm.
 34. The device of claim 31, wherein theconfiguration of the elongate body between the first location and thesecond location is generally conical when the elongate body is locatedwithin the patient.
 35. The device of claim 31, wherein the firstlocation is at a distal end of the elongate body, and the secondlocation is at a proximal end of the elongate body.
 36. The device ofclaim 31, wherein the elongate body is configured to be inserted throughthe skin of the patient and is sized to provide access to a spinallocation.
 37. The device of claim 31, wherein the elongate body ismovable from a first configuration to a second configuration whenlocated within the patient, the second configuration providing thecross-sectional area of said passage at a first location greater thanthe cross-sectional area of said passage at a second location, whereinthe first location is distal to the second location.
 38. The device ofclaim 37, wherein the elongate body is expandable from the firstconfiguration to the second configuration.
 39. A method for accessing asurgical location within a patient, comprising: providing a devicecomprising an elongate body having a proximal end, a distal end, and aninner surface, said inner surface defining a passage extending throughthe elongate body and through which surgical instruments can be insertedto the surgical location, said passage capable of having an oblongshaped cross section near the proximal end, and an expandedconfiguration; configuring said elongate body for insertion into thepatient; inserting the device into the patient to the surgical location;and expanding the device to the expanded configuration, such that thecross-sectional area of said passage at a first location is greater thanthe cross-sectional area of said passage at a second location, whereinthe first location is distal to the second location.
 40. The method ofclaim 39, wherein the device is inserted laterally to a spinal location.41. The method of claim 39, wherein the device is insertedposterolaterally to a spinal location.
 42. The method of claim 39,wherein the device is inserted anteriorly to a spinal location.
 43. Themethod of claim 39, wherein the device is expanded in a cephalad-caudaldirection at a spinal location.
 44. The method of claim 39, additionallycomprising inserting an oblong shaped dilator into the patient.
 45. Themethod of claim 39, wherein the device provides access to perform aspinal fixation procedure.
 46. The method of claim 45, wherein thedevice provides access to perform a two level posterolateral fixation ofthe spine.
 47. The method of claim 39, wherein the device providesaccess to deliver a spinal implant.
 48. The method of claim 47, whereinthe spinal implant is a fusion device.
 49. The method of claim 47,wherein the spinal implant is a prosthetic disc.
 50. A device forproviding access to a surgical location within a patient, said devicecomprising: an elongate body having a proximal end, a distal end, and aninner surface, said inner surface defining a passage extending throughthe elongate body and through which surgical instruments can be insertedto the surgical location, said elongate body capable of having aconfiguration when located within the patient wherein thecross-sectional area of said passage at a first location is greater thanthe cross-sectional area of said passage at a second location, whereinthe first location is distal to the second location; and a lightingelement coupled with said elongate body to provide light to the surgicallocation.
 51. The device of claim 50, wherein said passage is capable ofhaving an oblong shaped cross section between the second location andthe proximal end.
 52. The device of claim 50, wherein the configurationof the elongate body between the first location and the second locationis generally conical when the elongate body is located within thepatient.
 53. The device of claim 50, wherein the elongate body isconfigured to be inserted through the skin of the patient and is sizedto provide access to a spinal location.
 54. The device of claim 50,wherein the elongate body is movable from a first configuration to asecond configuration when located within the patient, the secondconfiguration providing the cross-sectional area of said passage at afirst location greater than the cross-sectional area of said passage ata second location, wherein the first location is distal to the secondlocation.
 55. The device of claim 54, wherein the elongate body isexpandable from the first configuration to the second configuration. 56.The device of claim 54, wherein the elongate body has an oblong shapedcross section at its proximal end at least when the elongate body is inthe second configuration.
 57. The device of claim 54, wherein thelighting element has a proximal end and a distal end, wherein theproximal end is coupled with a light source.
 58. The device of claim 54,wherein the lighting element has a proximal end and a distal end,wherein the proximal end is coupled with a mechanical arm.
 59. Thedevice of claim 54, wherein the lighting element is coupled with asupport member, wherein the support member extends generallyperpendicular to the lighting element.